483 Response of SCA

DocuSign Envelope ID: EB22856B-7133-40AD-87C4-99A0C1AACECD
- pharma
November 10, 2023
Lisa Harlan
10 Waterview Blvd.
3rd Floor, Suite 300
Parsippany, NJ 07054
RE: Inspection of SCA Pharmaceuticals, LLC Windsor, CT Facility (September 18th – October 20th,
2023) FEI #3013736415
Dear Ms. Harlan,
Attached please find the Responses of SCA Pharmaceuticals, LLC (SCA) to the Observations identified by
FDA in the Form 483 issued to SCA’s Windsor, Connecticut facility on October 20th, 2023. For those actions
still underway, we will provide a progress report no later than December 8th, 2023, with quarterly updates
to follow, and will be glad to report at earlier intervals as and if circumstances so warrant or FDA so
requests.
We appreciate the review of our facility and Quality Systems by the FDA Investigators and take their
discussion items and observations seriously. SCA is committed to operating in a manner that is consistent
with FDA regulations, guidance and expectations for 503B Outsourcing Facilities and this commitment
emanates throughout our organization, starting at the top. We trust the actions outlined in our Response,
along with ongoing improvement initiatives, support our commitment to producing safe drug products in
an environment that meets cGMP requirements.
SCA is fully committed to providing patients with high-quality compounded preparations. The enclosed
responses to FDA’s 483 observations demonstrate SCA’s sincere and comprehensive focus on continuous
improvement. If FDA would like to further discuss any items discussed between SCA and the investigators
during the closeout, SCA welcomes a meeting with the Agency at any time.
We look forward to the close-out of this inspection and issuance of an EIR.
If you should have any questions, please do not hesitate to reach out.
Sincerely,
______________________________
Scott Luce
CEO
OBSERVATIONS
OBSERVATION 1
There is no quality control unit.
Specifically,
A. The firm's investigation process is deficient in that the firm does not require identification of
particulates found during the visual inspection process.
B. The firm's visual inspection process governed by SOP ILP-001-W "Product Inspection and Defect
Classification" effective 2/22/2023 is deficient in that the SOP does not require the opening of an
investigation after a failure of the 100% visual inspection.
For example, in the last 6 months your firm has performed 100% visual inspection on
approximately 3663 batches and approximately 783 failed 100% visual inspection. These batches
were released without an investigation because the firm's visual inspectional AQL passed.
Furthermore, your SOP does not require an investigation after an AQL failure, unless a critical
defect is found, or an investigation after a second 100% inspection failure. In the last 6 months
you have had approximately 55 instances where you had a 100% visual inspection failure, AQL
failure, a second 100% visual inspection failure, and a passing tightened AQL and an investigation
is not always opened. Examples of products released by Quality are included in the following
chart 1.
C. In addition, your visual inspection process is deficient. For example:

a. The visual inspection SOP ILP-001-W "Product Inspection and Defect Classification" is
deficient in that an AQL failure after a passing of 100% visual inspection does not trigger
a retraining your Visual Inspector employees.
b. Production employees perform the AQL and tightened AQL, Quality does not perform the
AQL Visual inspection.
OBSERVATION 1 RESPONSE
SCA’s Windsor location has an independent Quality Control Unit that reports to SCA’s SVP of Quality and
is governed by MAN-001, Quality Manual, and SOP QMS-027, Responsibilities of the Quality Unit.
Reference Exhibits O1-1 and O1-2. The Quality department includes approximately 83 personnel with 22
personnel that monitor Windsor production activities on all shifts. Batch records, visual inspection results
and associated test results are reviewed and approved by Quality. Product does not leave SCA’s Windsor
location for distribution without review and release by trained Quality personnel.
1
Chart omitted for response purposes.
SCA CONFIDENTIAL Page 2 of 33

- pharma
SCA notified the Agency of the intent to recall on 06Nov23 and formally initiated Recall 23-004-W on
09Nov23 for products within expiry that did not meet Acceptable Quality Limit (AQL) specifications or that
had a <95% post visual inspection yield.
Prior to the FDA’s inspection, SCA self-initiated CAPA-2022-0034 on 23Sep22 related to the visual
inspection process. The following activities were completed by SCA’s Operations Department as part of
that CAPA:
• Formalized a logbook requirement to document eye breaks for visual inspection employees;
• Implemented daily light box LUX verification to ensure brightness of lights comply with USP
<1790> requirements; and
• Installed and validated “pacing lights” (located within view of inspectors) to operate as timers to
instruct inspectors to switch between black and white background, in order to standardize
amount of time each inspector examines each unit for consistency.
Once all such activities were complete, the CAPA was transferred to the Quality department, which
completed the following activities:
• Identified and vetted potential third-party consultants specializing in visual inspection to assist in
identification and execution of enhancements;
• Selected and qualified a well-known visual inspection industry expert to assist SCA (who was then
added to SCA’s Approved Supplier List);
• Enrolled Quality and Operations employees in Parenteral Drug Association (PDA) conferences to
continue educating SCA employees on industry standards and best practices on visual inspection;
• Examined potential changes and enhancements to “defect kits” used to train visual inspectors;
and
• Examined USP <1790>, USP <790> and FDA Draft Guidance on Visual Inspection and identified
enhancements that could be made to SCA’s visual inspection program based on same.
The visual inspection consultant (who had already been assisting SCA remotely) was scheduled to arrive
at the Windsor facility on 23Oct23. Reference Exhibit O1-3. However, the FDA inspection was still ongoing
in early and mid-October and it was unclear to SCA whether FDA would still be onsite in Windsor on
23Oct23. As such, the visual inspection consultant was rescheduled and arrived at SCA’s facility on
01Nov23 and began working with SCA on the implementation of CAPA-2022-0034.
MOC-2023-0129 was initiated on 01Nov23 to implement the following as part of the revision to SOP ILP-
001-W, Product Inspection and Defect Classification:
• Requirement to investigate if the 100% visual inspection for any lot that exceeds the relevant
criteria for each category;
• Requirement to initiate an investigation for any lot that fails AQL inspection;
• Requirement to identify particles during investigations for particulate;
• Requirement for scientific rationale to be included in investigations and approval by Quality prior
to performing a second 100% visual inspection and tightened AQL;
• Requirement to retrain visual inspectors when an AQL failure follows a prior 100% visual
inspection that met the relevant criteria. This retraining will be tracked and trended per Visual
Inspector for assessment of competency; and

- pharma
• Requirement that the Quality Assurance unit assume all responsibilities related to performance
of the AQL process.
SOP ILP-001-W was revised per DAR-23-271 and made effective on 09Nov23. Reference Exhibit O1-4.
Inspection, Labeling and Packaging employees were trained starting on 09Nov23. SCA will not permit
anyone to perform inspection, labeling and packaging duties until all training requirements have been
completed.
Prior to 08Dec23, the Quality department will perform a minimum of three (3) observations of the visual
inspection process (including AQL) to ensure compliance.
To supplement the revision to SOP ILP-001-W, the following forms were revised per DAR-23-521.
Reference Exhibit O1-5:
• Form ILP-001-4-W, ILP Signature Log and Bag 100% Inspection Form
• Form ILP-001-5-W, Bag AQL Inspection Form
• Form ILP-001-6-W, Bag Additional 100% Inspection Form
• Form ILP-001-7-W, Bag TAQL Inspection Form
• Form ILP-001-8-W, ILP Signature Log and Syringe 100% Inspection Form
• Form ILP-001-9-W, Syringe AQL Inspection Form
• Form ILP-001-10-W, Syringe Additional 100% Inspection Form
• Form ILP-001-11-W, Syringe TAQL Inspection Form
• Form ILP-001-12-W, ILP Signature Log and CADD 100% Inspection Form
• Form ILP-001-13-W, CADD AQL Inspection Form
• Form ILP-001-14-W, CADD Additional 100% Inspection Form
• Form ILP-001-15-W, CADD TAQL Inspection Form
OBSERVATION 2
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate
phase of manufacturing of the drug product.
Specifically,
The visual inspection % yield is not calculated or established in the batch record or is an established quality
parameter. For example, the following batches were compounded and released.
A. Batch record for Hydromorphone HCL mg/mL in 0.9% Sodium Chloride 30mL fill 35mL Plungerless
Syringe, Lot number 1223048865, shows 372 compounded units released to visual inspection and
after the visual inspection rejection the amount of product released to labeling was 249 units,
which had an approximate yield of 70%.
B. Batch record for Fentanyl 50mcg/mL 50mL bag, Lot number 1223048351, shows 286 compounded
units released to visual inspection and after visual inspection rejection the amount of product
released to labeling was 246 units, which had an approximate yield of 86%.

- pharma
C. Batch record for Hydromorphone HCL 0.2 mg/mL in 0.9% Sodium Chloride 30mL fill 35mL
Plungerless Syringe, Lot number 1223049559, shows 306 compounded units released to visual
inspection and after visual inspection rejection the amount of product released to labeling was
226 units, which had an approximate yield of 74%.
At the time of the inspection, compounding production yields were being calculated and recorded in the
manufacturing batch record and an investigation is initiated when the cause of the yield is unknown.
Prior to the FDA inspection, as detailed above, SCA engaged a third-party expert to assist with
enhancements to our visual inspection process. As such, and in response to Observation 2, our already-
engaged third-party consultant worked with us to define the appropriate yield requirement of not less
than (NLT) 95%.
The post visual inspection % yield target of NLT 95% was implemented on 09Nov23 as part of DAR-23-271
for SOP ILP-001-W, Product Inspection and Defect Classification. Reference Exhibit O1-4. Any batch that
does not meet the established visual inspection yield criteria will result in the initiation of an event per
SOP QMS-039, Event Reporting and Disposition. Events are evaluated for potential product impact by
Quality Assurance personnel and then, when required, elevated to a deviation and investigated following
SOP QMS-003, Deviation Management.
Prior to and at the time of the inspection SCA did (and still does) record the number of units sent to
Inspection, Label, Pack (ILP) for inspection as well as the number of discarded units (rejects). As such, SCA
conducted a retrospective review of this data, to identify any lots in the market that did not meet the
yield requirement of NLT 95%. Although SCA is not aware of any adverse events associated with these
products, in an abundance of caution, SCA notified the Agency of the intent to recall specific lots on
06Nov23 and formally initiated Recall 23-004-W on 09Nov23 of any Windsor product within expiry where
the retrospective data analysis indicates failure to meet the post inspection yield outside of the NLT 95%
criteria.
OBSERVATION 3
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its
components to meet any of its specifications whether or not the batch has been already distributed.
Specifically,
A. Your SOP TM 008 "USP <788> Particulate Matter" is deficient in that after a failure of Test Method
1 (Light Obscuration Particle Count Test) than Test Method 2 (Microscopic Particle Count Test) is
performed.
a. Your SOP states that If after a failure of Test Method 1 and a passing of Test Method 2,
the product can be released and distributed without opening an investigation.

For example, since 2019 there were approximately 38 instances where there was a failure of Test Method
1 and a Passing of Test Method 2 without opening an investigation. For example, see the chart below 2.
These products have been released and distributed.
B. Since December 2019, the firm has documented twenty-nine (29) Out of Specifications (OOS)
results for in-house sterility testing of finished drug products intended to be sterile using a rapid
scan method (BioMerieux ScanRDI). All batches were rejected; however, the firm failed to
adequately investigate and remediate all potential sources of microbial contamination including
spore-forming microbes.
For example: Out of Specification (OOS-2023-0069) initiated on or about 29-Aug-2023 identified

circular spore like structures in lot# 1223048877 (Phenylephrine HCl 40 mcg/mL in 0.9per Sodium
Chloride 10 mL fill 12 mL Syringe 400 mcg 10 mL). The firm's accompanying manufacturing
deviation (DEV-2023-0435) identified inadequate material sanitization and poor aseptic
technique demonstrated by the Compounder as identified causes; however, the firm failed to
identify Sanitization Technicians also wiped totes with IPA wipes prior to meeting the firm's
established sporicidal disinfectant contact time of 5 minutes. On 26-SEP-2023 via the firm's
Avigilon video recordings, sporicidal disinfectant contact times for the 10 totes associated with
lot 1223048877 were observed to be as low as 63 seconds before Sanitization Technicians wiped
the totes with IPA. The firm's investigation remains open.
In addition, there is no assurance the firm's remediation actions for all sterility OOSs and
accompanying manufacturing deviations are adequate, specifically for spore-forming microbes.
For example: the firm's corrective and preventative actions included retraining of individual
Compounders, Aseptic Assistants, and Sanitization Technicians associated with specific sterility
OOSs, and the firm opened CAPA-2023-0017 in response to a lack of standardized material
sanitization by firm personnel, which was associated with five (5) sterility OOSs that occurred in
April of 2023; however, the CAPA due date for training of all staff is not until 31-JAN-2024 and six
(6) of the firm's last 10 sterility OOSs identified spores or spore-forming microbe morphologies.
For additional example, on 1-OCT-2023, the firm opened DEV-2023-0525 as a result of a failed
media fill. The firm identified the microbe from the failed media fill as genius Bacillus, a spore-
forming bacterial microbe.
C. The firm failed to adequately assess and remediate numerous findings of foreign materials,
described as cardboard and hair, found in sterile starting material syringe tray packs from the
firm's three (3) syringe suppliers. Since January 2022, the firm documented numerous incidences
of foreign materials found in syringe tray packs during production within ISO-5 environments via
Form QA-014-01, Foreign Material Documentation forms. The firm trends starting material lots
found with foreign materials and rejects in-process product found to be associated with tray packs
in which foreign material was identified; however, there is no assurance all foreign material is
found and removed as the firm does not qualify operators to identified foreign materials, the firm
2
Chart omitted for response purposes.

- pharma
does not track or trend operators who identifying foreign materials, and the firm continues to use
the same suppliers.
D. The firm failed to adequately address 100% visual inspection and AQL failures. The firm opened
CAPA-2022-0034 (Corrective Action and Preventive Action) on 23 Sep 2022 with a CAPA due date
of23 JUN 2024. A CAPA action plan was signed by Quality on 23 Jun 23, The action plan includes
opening an investigation after 100% Visual Inspection failure. Since 23 Jun 23, the firm has had
approximately 480 lots that failed 100% inspection, without an investigation being opened.
SCA follows an event reporting and classification process per SOP QMS-039, Event Reporting and
Disposition. The events are evaluated for potential product impact by Quality Assurance personnel and
then elevated to a deviation when required per SOP QMS-003, Deviation Management. An impact
assessment for the lot and distributed products on the market is required per the procedure and
documented in the respective event or deviation.
OBSERVATION 3A RESPONSE
SCA looks forward to the Agency publishing its long-awaited regulations on Current Good Manufacturing
Practice for Outsourcing Facilities. In the meantime, SCA follows cGMP Guidance for Human Drug
Compounding Outsourcing Facilities which provides for use of USP <788> for particle testing. Per USP
<788>, Particulate Matter in Injections, the Method 1 Light Obscuration Particle Count Test Evaluation
section states ‘If the average number of particles exceeds the limits, test the preparation by the
Microscopic Particle Count Test’ which is Method 2. Reference Exhibit O3-1. Therefore, cGMP and USP
both indicate that it is appropriate to perform Test Method 2 should Test Method 1 exceed the limit, as is
SCA’s current process. There is no quality or safety risk to patients for SCA product in the market that
exceeded the limit for Test Method 1 and subsequently met the limit for Test Method 2.
However, TM-008, Particulate Matter, was revised per DAR-23-511 and made effective on 06Nov23.
Reference Exhibit O3-2. This revision requires initiation of an investigation per SOP CHEM-038, Handling
Out of Specification and Out of Trend Results, when there is an exceedance of particulate matter limits
during Test Method 1 – Light Obscuration, regardless of whether the Method 2 results are acceptable.
This investigation will ensure that there were no laboratory errors during the performance of Test Method
1.
There have been no Test Method 1 or Test Method 2 testing exceedances since the close of the inspection
on 20Oct23.
OBSERVATION 3B RESPONSE
SCA has rejected (prior to distribution) all product that has been found to be Out of Specification (OOS)
for sterility. SCA notes that the sterility failures referenced in Observation 3B represent a 0.1% failure rate
since December 2019. More recently, and specifically over the past year, SCA Windsor’s sterility
performance has been as follows: Q4 2022: 100% within specification; Q1 2023: 100% within specification;
Q2 2023 99.68% within specification; and Q3 2023: 100% within specification.

- pharma
The investigations into the 29 failures in Windsor over the past ~4 years (0.1% of lots produced in Windsor)
were completed per the requirements of QMS SOP-003, Deviation Management. On 20Jul23, SCA self-
initiated CAPA-2023-0017 in response to the manufacturing trend investigation of sterility failures. SCA’s
CAPA plan that was already in place at the time of the inspection, included two action items:
• Revision to SOP SAN-002-W, Movement of Materials Into and Out of Classified Areas, to
implement a sporicidal sanitization step to the IV bag overwrap during the material sanitization
process. This action item had an original target due date of 31Dec23. However, this SOP revision
per DAR-23-443 has been completed and was made effective on 10Nov23. Reference Exhibit O3-
3. Cleanroom personnel training began on 10Nov23. SCA will not permit anyone to perform
cleanroom duties until all training requirements listed in all relevant responses have been
completed.
• Creation of material sanitization training videos to standardize wiping technique for the material
sanitization staff and the cleanroom compounding staff. This action item had an original target
due date of 31Dec23. However, the creation of training materials was completed on 08Nov23 and
delivery of the training videos began on 10Nov23 and will continue until all cleanroom personnel
have been trained. SCA will not permit anyone to perform cleanroom duties until all training
requirements have been completed.
At the time of inspection, DEV-2023-0435 had already been initiated and was still open and in the process
of being investigated before the Agency made an observation related to totes and contact time. Because
the deviation was open at the time of the FDA inspection, SCA was able to include the Investigator’s
observations, along with corresponding corrective actions (SOP SAN-002-W revision and training
referenced in Observation 4B) within the investigation prior to closure on 26Oct23. Reference Exhibits
O3-3, O3-4 and O4-2.
In addition, SCA has been migrating from the ScanRDI sterility test to a more advanced methodology using
the Celsis Advance II Rapid Microbial Detection System. SCA purchased two Celsis Advance II Rapid
Microbial Detection Systems manufactured by Charles River for its Windsor facility, which were installed
and qualified on 10Aug22 and 06Oct23. Method suitability has been completed for 28 product families
and 4 product families remain. Despite our best efforts, we have been unable to bring the two Celsis
instruments online and operational because the specific type of media that is required to be used with
this equipment is currently on shortage and backorder.
OBSERVATION 3C RESPONSE
SCA has revised SOP QA-014 per DAR-23-520 to reference the newly developed visual display VD-QA-014-
2, Visual Display for Defect Examples, to aid operators in identifying commonly found foreign material.
Reference Exhibits O3-5 and O3-6. The SOP revision includes a requirement to update the visual display
when operators identify a new unique type of foreign material. Cleanroom personnel will be required to
train on SOP QA-014 and VD-QA-014-2 minimally on an annual basis (or sooner if the SOP and VD are
updated) to ensure operators are familiar with the types of foreign material they may encounter when
compounding. Additionally, cleanroom personnel will be required to attend classroom training beginning
on 13Nov23, where examples of defects will be presented. SCA will not permit anyone to perform
cleanroom duties until all training requirements have been completed.

- pharma
SCA will begin tracking and trending cleanroom operators for the identification of foreign material. Form
QA-014-01, Foreign Material Documentation Form, was revised per DAR-23-520 and made effective on
09Nov23 to document which compounder identified the foreign material. Reference Exhibit O3-7. In
addition, SCA revised technical qualification TQ COM-100-2-W, Aseptic Assistant Technical Qualification,
per DAR-23-527 to require a step for training on defect types for any newly hired cleanroom personnel.
This technical qualification was made effective on 09Nov23. Reference Exhibit O3-8.
SCA currently uses three (3) reputable, FDA-registered syringe suppliers (whose names we would be glad
to supply upon request) from among the small set of FDA-registered syringe suppliers. Of those three
suppliers used by SCA, two manufacture, kit and sterilize syringes, while the third supplier obtains non-
sterile, non-kitted syringes from an FDA-registered facility and packages and sterilizes them for SCA.
SCA performed a review of already documented issues regarding foreign material in supplier-provided
syringe trays and, on 10Oct23, initiated formal supplier complaints, SUP-2023-0026, SUP-2023-0027 and
SUP-2023-0028 to each supplier regarding defects found in their supplied products. SCA has not yet
received any corrective actions from two of the suppliers, in response to the complaints issued to them
by SCA. Therefore, on 13Nov23, SCA plans to issue escalation letters describing our concerns to those two
suppliers. The intent of these letters is to escalate the issue to the suppliers’ Quality Leadership team to
ensure corrective actions are implemented. SCA has received communication from the third syringe
supplier, who, in response to our complaint, has requested a Quality meeting with SCA to discuss the
identified defects and the corrective actions in response to the defects. SCA plans to participate in the
meeting and, if the corrective actions presented by the supplier are deemed inadequate or not met, SCA
will issue an escalation letter to the supplier as above.
Given the relatively small set of FDA-registered suppliers for these products, SCA has very few options for
alternatives. That noted, SCA is currently evaluating a fourth syringe supplier, selection of which would
require SCA to establish new product stability data using a different container closure type. If the
container is a viable option, the project would be a long-term solution and a change control would be
initiated at the time of project start.
OBSERVATION 3D RESPONSE
Reference the response to Observation 1.
OBSERVATION 4
Written procedures are not established and followed for the cleaning and maintenance of equipment,
including utensils, used in the manufacture, processing, packing or holding of a drug product.
Specifically,
A. There are no established procedures for preparing Spor-Klenz wipes used to sanitize all starting
compounding materials, totes, and cleanroom equipment such as the firm's ISO-5 Horizontal
Laminar Flow Hoods, to ensure consistency and adequacy of cleaning. The firm prepares Spor-
Klenz wipes used to sanitize starting materials and totes by adding an undefined amount of Spor-
Klenz from a gallon container into a Contec non-sterile and low linting Sanotex Environmental
Surface Wipes container. The firm prepares Spor-Klenz wipes used to perform nightly cleaning of

- pharma
the ISO-5 hoods by adding an undefined amount of Spor-Klenz from a gallon container into a mop
bucket containing an undefined amount of Berkshire Corporation sterile Gamma Wipes.
B. Polypropylene totes used to transfer all compounding materials from an unclassified staging area
(room 252) to the ISO-7 compounding suite (rooms 1102, 1104, 1107, & 1110) and placed
immediately adjacent to ISO-5 Horizontal Laminar Flow Hoods are not adequately sanitized.
Sanitization technicians were observed to wipe totes with IPA wipes prior to meeting the firm's
established Spor-Klenz contact time of 5 minutes. For example, Spor-Klenz contact times for 10
totes associated with lot 1223048877 (Phenylephrine HCI 40mcg/ml in Sodium Chloride 10mL fill
in 12 mL Syringes) were observed to be as low as 63 seconds before being wiped with IPA. The
firm currently has an open sterility OOS for lot 1223048877.
C. The firm uses Spor-Klenz wipes to perform nightly sporicidal cleanings of top, side walls, and deck
of the firm's 15 ISO-5 Horizontal Laminar Flow Hoods used to produce product purported to be
sterile; however, the firm does not perform periodic sporicidal cleanings of the grate covering the
HEPA filter for any of the hoods. The firm has not performed a risk assessment for this practice.
SCA has multiple procedures established for the cleaning and maintenance of equipment used in the
manufacturing and cleanroom environments. These procedures include instructions on the preparation
of sanitizing agents and wipes, laminar air flow hoods and the associated grates, and other utensils used
in the manufacture, processing, packing and holding of drug products. SCA is further enhancing its policies
and procedures on cleaning and maintenance of equipment Specific cleaning and maintenance
procedures are included in the individual responses below.
SOP SAN-002-W, Material Movement into and out of Classified Areas, currently contains a requirement to
ensure the wipe is saturated prior to use. In addition, SOP SAN-001-W, Cleaning of Classified Areas, also
instructs operators to ensure wipes are saturated during the preparation process. Furthermore, SCA will
start utilizing pre-saturated sterile Sporklenz wipes, which have been qualified by the manufacturer and
will eliminate the potential for any operator variability in preparing the wipes (including amount of
saturation) when we sanitize rooms and materials in advance of resumption of production. SCA has
revised SOP SAN-002-W and SOP SAN-001-W, both effective on 10Nov23, to require the use of
commercial, pre-saturated Sporklenz wipes. Reference Exhibits O3-3 and O4-1. SCA will also immediately
cease the use of the wipes referenced in the Observation in the ISO 8 environment for material
sanitization. This change is also captured in the revision to SOP SAN-002-W. Reference Exhibit O3-3.
Additionally, cleanroom personnel are required to attend in-person classroom training, where this process
change will be presented. The training program was initiated on 10Nov23. SCA will not permit anyone to
perform cleanroom duties until all training requirements have been completed.
As a process improvement, SCA initiated ES-23-026, Engineering Study for the Efficacy of Wipe Preparation
and Cleaning of Cleanroom Materials and Equipment, per TASK-23-1070 on 08Nov23. This engineering
study will be performed to develop a cleaning method which will include internal preparation of Sporklenz

- pharma
wipes using sterile wipes and ready to use Sporklenz solution. The target completion date of this
engineering study is 30Nov23. After performance of this study, a cleaning method qualification per VAL-
23-074, Cleaning Qualification of Prepared Sanitization Wipes on Cleanroom Materials and Equipment will
be executed, and relevant procedures will be updated. The target completion date for this study and SOP
revisions is 31Dec23.
There is no risk to previously compounded product as current SOPs include instruction to ensure wipes
are saturated before use. Additionally, any microbial contamination identified within the ISO 5
environment requires an investigation prior to disposition of the batch.
SOP SAN-002-W was revised to specify the requirement for totes to meet the 5-minute sporicidal contact
time and became effective on 10Nov23. This procedure update removed an IPA wipe of the totes.
Reference Exhibit O3-3. In addition, during the FDA inspection, on 04Oct23, the material sanitization
department was immediately re-trained on contact times per SOP SAN-002-W. Reference Exhibit O4-2.
Between 04Oct23 and 02Nov23, cleanroom management performed random surveillance of the material
sanitization process to ensure compliance with the requirement for 5-minute sporicidal contact time for
totes. All monitoring activities have confirmed compliance with the procedure.
Prior to 08Dec23, the Quality department will perform a minimum of three (3) observations of the tote
sanitization process to ensure compliance.
Though the FDA Form 483 indicated that SCA does not periodically clean laminar airflow hood (LAFH)
grates, SCA does in fact periodically clean LAFH grates on a six-month frequency during bi-annual LAFH
and cleanroom recertification activities. Per SOP COM-060-W, Use and Operation of Laminar Airflow
Hoods, the HEPA diffuser is cleaned as part of containment activities for a drug spill.
SCA will conduct an engineering study per ES-23-027, Engineering Study for Grate Cleaning Frequency, to
determine whether more frequent cleaning intervals may enhance the cleaning program. The target
completion date is 31Jan24.
Per SOP SAN-001-W, Cleaning of Classified Areas, specified LAFHs surfaces are cleaned daily with
Sporklenz followed by a sterile 70% IPA residual removal clean. LAFH’s are cleaned in the following order:
inside top, bar and hooks (if present), side walls, hood deck. The HEPA filter diffusers are not required to
be cleaned daily to avoid wetting the HEPA media which could compromise the integrity of the filter.
Environmental monitoring is performed for all batches compounded in the LAFH ISO 5 environment. Batch
related environmental monitoring includes, but is not limited to, active viable air sampling and continuous
non-viable particulate sampling, where the air samplers are pointed in the direction of the HEPA diffuser
which includes detection of any potential contamination from the filtered air. These samples are used to
provide evidence that the LAFH functions as intended and remains in a state of control during

- pharma
compounding activities. There are no negative trends in active viable air sampling and continuous non-
viable particulate sampling demonstrating effectiveness of the process.
OBSERVATION 5
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile

are not written.
Specifically,
A. Operators failed to follow techniques intended to maintain sterility of items and surfaces during
aseptic operations. For example, on 18-SEP-2023, during production of lot 1223049390 Fentanyl
20mcg/mL in 0.9% Sodium Chloride 100mL Bags in bay CT0120, hood #7/2, Aseptic Assistant (PJ)
was observed to touch items including totes, a chair, repeater pumps, gowning, and subsequently
reached into the ISO-5 hood to provide additional starting materials and retrieve finished product
without sanitizing hands or changing gloves. In addition, upon review of the firm's Avigilon video
recordings, Aseptic Assistant (PJ) touched the surface of a table where non-sterile paper and label
items were located, as well as the paper batch record, and subsequently reached into the ISO-5
hood to provide additional starting materials and retrieve finished product without sanitizing
hands or changing gloves. The firm's SOP (COM-001-W) requires operators to don new sterile
gloves or sanitize gloves with 70% IPA prior to staging material into and collecting material out of
1SO-5 hoods. Lot 1223049390 was approved by Quality on 26- SEP-2023.
B. The firm failed to ensure adequate cleanroom airflow to not potentially compromise aseptic
operations. For example, on 18-SEP-2023, during production of lot 1223049390 Fentanyl
20mcg/mL in in 0.9% per Sodium Chloride 100mL Bags in bay CT0120, hood #7/2, air return vents
for the firm's HVAC system, located in half walls separating the firm's ISO-5 hoods, were observed
to be obstructed. The firm's SOP (SAN-002-W) requires materials or totes on carts to be stored in
a manner that does not block airflow for air return vents.
SCA requires all personnel working in classified environments to be trained on SOP COM-001-W, Aseptic
Guidelines and Cleanroom Behavior. The procedure is detailed in the actions required for proper aseptic
techniques and references additional procedurals that contain further requirements for specific actions
and operations. SCA is further enhancing its training to include additional training for personnel and
formal monitoring processes for aseptic behavior which were implemented as detailed.
SCA’s entire compounding staff were retrained on proper glove sanitization and glove changes on
01Nov23. Reference Exhibit O5-1. In addition, SCA retrained an aseptic assistant on 19Sep23. Reference
Exhibit O5-2.

- pharma
Additional corrective actions and process improvements include:
• SCA has procedurally defined how far reaching an aseptic assistant can place their hands into
the ISO 5 environment. SOP COM-018-W, Staging of Raw Material in the LAFH, has been revised
per DAR-23-531 to include instructions that the aseptic assistant can only place their gloved
hand into the ISO 5 environment and no part of their gown can enter the ISO 5 LAFH. This
procedure was made effective on 09Nov23. Reference Exhibit O5-3.
• CAPA-2023-0028 was initiated on 03Nov23 to enhance SCA’s current aseptic technique and
cleanroom behavior training for all gowning qualified staff. The CAPA includes training on
cleanroom design, layout, and engineering controls as well as training on how people and
behavior may impact the cleanroom environment. As part of this CAPA, the following actions
have been completed:
• SOP COM-061-W, Roles and Responsibilities of Cleanroom Personnel, was revised and
made effective on 09Nov23 per DAR-23-512 to require cleanroom pharmacists,
supervisors and lead technicians to perform daily observation of cleanroom personnel to
ensure adherence to all SOPs. Reference Exhibit O5-4.
• SCA developed a “Micro on the Floor” program in which the Microbiology department
will conduct routine assessments of cleanroom behavior and technique as part of SCA’s
overall contamination control strategy. Procedure SOP LAB-074-W, Microbiology Quality
Oversight of Critical Areas, was made effective on 09Nov23 per DAR-23-516. Reference
Exhibit O5-5.
• SCA developed a “Micro 101” training for gowning qualified personnel that provides a
refresher on the basics of microorganisms, sources of contamination, how microbes are
transmitted, and how hygiene and behavior can increase or decrease the spread of
bacteria. Reference Exhibit O5-6.
o Any new personnel will receive this training prior to being qualified to enter the
cleanroom, and existing personnel will be re-trained on a semi-annual basis.
• SCA developed a “Cleanroom 101” training for gowning qualified personnel that
provides a refresher on cleanroom disinfection practices, room classifications and
cleanroom engineering controls such as airflow, pressure, and building materials.
Reference Exhibit O5-7.
o Any new personnel will receive this training prior to being qualified to enter the
cleanroom, and existing personnel will be re-trained on a semi-annual basis.
Cleanroom personnel were trained on the relevant process changes and SOP revisions starting on
10Nov23. SCA will not permit anyone to perform cleanroom duties until all training requirements listed in
all relevant responses have been completed. Routine monitoring and oversight to ensure adherence to
these process changes and SOP revisions will be performed as stated in SOP COM-061-W and SOP LAB-
074-W.

- pharma
SCA also commits to implementing long term corrective actions which include:
• Converting paper tote tags to disposable metal tags (MOC-2023-0137) – Target Completion Date
of 29Feb24
• Implement a process to autoclave batch records (MOC-2023-0142) – Target Completion Date of
29Feb24
SCA conducted thirty-three (33) independent Airflow Visualization (Smoke) Studies for all four (4) ISO 7
compounding cleanrooms used to support the fifteen (15) Laminar Flow Hoods. All rooms were loaded to
normal operating conditions including carts, tables, and totes used during compounding activities and
included partially blocked returns by waste bins and totes as a worst-case loading condition. Dynamic
airflow visualization was performed and included the maximum occupancy of gowned personnel for each
room as procedurally required, while operators simulated their routine duties. Though the rooms have
non unidirectional airflow, the airflow patterns were assessed to ensure that air was not traveling from
less clean areas (such as the floor) or over operators, equipment, or materials into the ISO 5 LAFHs.
All thirty-three (33) Airflow Visualization Studies showed airflow from the HEPA filters moving in a robust
downward manner before mixing with room air with no observable adverse airflow patterns. Clear
separation of clean spaces was demonstrated between the ISO 5 LAFHs and ISO 7 compounding rooms.
No evidence of refluxing or outside air entering the ISO 5 LAFHs was observed. Suitable mixing of tracer
particles (representing air flow) was observed and tracer particles in the room flowed away from the
LAFHs and into return vents.
Though SCA’s Airflow Visualization (Smoke) Studies are suitable, all cleanroom operators were re-trained
on the requirement in SOP SAN-002-W, Movement of Materials Into and Out of Classified Areas, to store
material in a manner that does not block airflow for air return vents on 01Nov23. Reference Exhibit O5-1.
Additional process improvements include:
• SOP COM-005-W, Compounding Area Clearance and LG-COM-005-1-W, Compounding Area and
Equipment Use Log, were revised per DAR-23-512 and were made effective on 09Nov23.
Reference Exhibits O5-8 and O5-9. These revisions require the compounder to perform pre and
post compounding checks of air returns to ensure they are not blocked. Documentation of each
check will be captured in LG COM-005-1-W.
• SOP COM-061-W, Roles and Responsibilities of Cleanroom Personnel, was revised per DAR-23-512
to include specific requirements for cleanroom pharmacists, supervisors and lead technicians, to
perform checks of air returns continuously throughout their shift. The procedure was made
effective on 09Nov23. Reference Exhibit O5-4.
Cleanroom personnel were trained on the relevant process changes and SOP revisions starting on
10Nov23. SCA will not permit anyone to perform cleanroom duties until all training requirements have
been completed.

- pharma
OBSERVATION 6
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Specifically,
The firm's environmental monitoring practices of classified and aseptic processing areas do not ensure
appropriate levels of environmental cleanliness. For example:
A. Personnel monitoring of gloved fingertips for Aseptic Assistants never occurs as part of the firm's
routine personnel monitoring program; however, Aseptic Assistants were observed reaching into
ISO-5 hoods to stage starting materials and collect finished products during production.
B. The firm's personnel monitoring action limit for the sleeves of Aseptic Assistants is > 10 colony
forming units (CFUs); however, Aseptic Assistants were observed to reach into hoods during
production. Since January 2020 there were 30 spore-forming microbial recoveries of < 10 CFUs on
the sleeves of Aseptic Assistants. The firm failed to investigate and assess product impact for any
of these spore-forming microbial recoveries.
C. The firm does not consider spore-forming bacteria recovered from classified environments as
objectionable unless action levels are reached. Since January 2020, the firm documented 404
media plates which identified spore-forming microbial recoveries from ISO-7 environments;
however, only recoveries with 10 CFUs or more are investigated.
D. The firm performs viable active air monitoring during compounding via SAS Super 180 Portable
Microbial Air Monitors; however, the monitor is placed to the far right of the ISO-5 hood with the
probe approximately six inches and directly facing the HEPA filter. The firm did not perform or
provided directionality studies or scientific justification for this practice.
E. Cleanroom items such totes, chair, and repeater pumps, observed to be touched by Aseptic
Assistants, are never sampled as part of the firm's routine environmental monitoring program.
SCA has a comprehensive Environmental Monitoring program and performs monitoring in all classified
areas with a focus on the ISO 5 environment where all aseptic manipulations occur. SCA designed and
documented the environmental and personnel monitoring program of the facility’s classified areas based
on a formal risk assessment, RA-21-001-W, Risk Assessment for Controlled Environments located at 755
Rainbow Rd, Windsor, CT 06095. Once sampling locations, method, criteria, and other supplemental
parameters were identified, the classified areas were successfully qualified as part of static and dynamic
environmental monitoring performance qualification. The product manufacturing processes were also
successfully qualified via aseptic process simulation (media fills) and continue to be regularly assessed
twice annually.
Since initial implementation, the risk assessment document has regularly been updated as part of the
lifecycle approach to the environmental and personnel monitoring program. Microbial trend data analysis

- pharma
as well as evolving regulatory requirements result in frequent re-evaluation of the monitoring program
including, but not limited to, sample frequency, sample site selection, alert/action levels, etc.
An Aseptic Assistant is an ISO 7 production operator who supports the ISO 5 Compounder in the
manufacturing of a batch. The Aseptic Assistant introduces and removes materials from the ISO 5 Laminar
Airflow Hood (LAFH) downstream from the critical compounding zone, thus mitigating risk of potential
microbial contamination. The interventions and described routine process flow of the Aseptic Assistant
have been successfully qualified in both Airflow Visualization (Smoke) Studies in addition to Aseptic
Process Simulations (Media Fills). The Airflow Visualization Studies show that there is no ingress of air into
the critical compounding zone by interventions of the Aseptic Assistant. The Aseptic Process Simulations
demonstrate that the interventions by the Aseptic Assistant do not result in contaminated final filled
units. Reference Exhibit O6-1.
Aseptic Assistants interact with the ISO 5 environment on the left side and right side of the LAFH. Sampling
of each batch includes continuous passive viable air monitoring on the left and right sides of the critical
zone from the connection of the sterile filter throughout the duration of batch filling. Additionally, a viable
surface sample is collected on the left and right side of the hood at the conclusion of compounding.
As part of enhancing SCA’s Environmental and Personnel Monitoring Program, SCA has initiated change
control MOC-2023-0130 to capture the implementation of new sampling locations within the classified
areas including, but not limited to, the gloved fingertips of ISO 7 Aseptic Assistants. As part of MOC-2023-
0130, Aseptic Assistant gloved fingertips will be sampled to improve the monitoring of the ISO 7
activities. As per MOC-2023-0131, the results from the Aseptic Assistant’s gloves will become batch
release criteria and any microbial recovery obtained from the gloves will result in a product impact
assessment. To support this process change, Risk Assessment RA-21-001-W and SOP LAB-007-W,
Environmental and Personnel Monitoring of Classified Areas have been revised per DAR-23-542. These
documents were made effective on 09Nov23. Reference Exhibits O6-2 and O6-3.
Training for Cleanroom and Microbiology personnel began on the relevant process changes and SOP
revisions starting on 10Nov23. SCA will not permit anyone to perform cleanroom duties or collect
personnel monitoring samples until all training requirements have been completed.
SCA has procedurally defined how far an Aseptic Assistant may place their hands into the ISO 5
environment. SOP COM-018-W, Staging of Raw Material into the LAFH, was revised to include instructions
that the Aseptic Assistant can only place their gloved hand into the ISO 5 environment, and no part of
their gown can enter the ISO 5 LAFH. This document was made effective on 09Nov23. Reference Exhibit
O5-3.
SCA has updated the action limit for ISO 7 personnel monitoring, which includes the Aseptic Assistant’s
gown sleeves, from <10 CFU to <5 CFU. To support this process change, Risk Assessment RA-21-001-W
and SOP LAB-007-W have been revised per DAR-23-542 and made effective on 09Nov23. Reference
Exhibits O6-2 and O6-3.

- pharma
As part of continuous improvement to the contamination control program, SCA has revised SOP LAB-030,
Trend Analysis of Environmental and Personnel Monitoring Results, per DAR-23-528, to proceduralize the
review of bacterial spore forming organisms recovered from the ISO 7 cleanroom and to identify and
investigate any potential trends that may develop. The target effective date of this SOP revision is
30Nov23.
Training for Cleanroom and Microbiology personnel began on the relevant process changes and SOP
revisions on 09Nov23. SCA will not permit anyone to perform cleanroom duties or collect personnel
monitoring samples until all training requirements have been completed.
As per RA-21-001-W and applicable governing internal standard operating procedure SOP LAB-007-W, the
facility has a no growth policy within the ISO 5 environments that considers any (and all) viable microbial
recoveries results actionable, therefore requiring a thorough investigation.
Per SOP LAB-007-W, fungi (including yeast and mold), are considered actionable in the Compounding
Rooms. A recovery of one (1) fungal colony forming unit in an ISO 7 Compounding Room results in an
actionable result and investigation. Under the risk-based assessment performed by SCA, spore forming
bacteria were not found to be, and therefore are not considered, objectionable in the ISO 7 and ISO 8
areas. Bacterial spore forming organisms are thoroughly investigated once the action level with respect
to number of colony forming units (CFU) is exceeded.
Between January 2020 to September 2023, approximately eighty-five percent (85%) of bacterial spore
forming organism recoveries at the site are comprised of unique species within the genus Bacillus. SCA
hired an independent third-party microbiological contamination control expert to assess each unique
bacterial spore forming genus and species recovered between January 2020 and September 2023 for
potential risk to patient. The assessment performed by that independent third-party contamination
control expert concluded that bacterial spore forming organisms recovered are not objectionable via
injectable mode of administration. Reference Exhibit O6-4.
As part of continuous improvement to the contamination control program, SCA has revised SOP LAB-030
per DAR-23-528 to proceduralize the review of bacterial spore forming organisms recovered within the
ISO 7 cleanroom to help identify and investigate any potential trends that may develop. The target
effective date is 30Nov23.
OBSERVATION 6D RESPONSE
SCA has a robust ISO 5 environmental and personnel monitoring sampling plan with a high level of
detection for viable and non-viable contamination. Each batch includes one active viable air sample during
filling of commercial units, continuous passive viable air monitoring which includes multiple sample plates
in the immediate critical compounding zone from the connection of the sterile filter throughout the
duration of batch filling and continuous non-viable particulate monitoring from connection of the sterile
filter throughout the duration of batch filling. SCA considers all samples in totality as part of final product
disposition performed by the Quality Assurance Department.
To further enhance SCA’s policies, SCA has initiated change control MOC-2023-0132 to capture the
improvement and optimization of active viable air sampler positioning. The active viable air sampler will

- pharma
be repositioned perpendicular to the HEPA Filter in the LAFH to face in the direction of the compounder
and the compounding process within 12-18 inches of the critical zone. The results of the active viable air
monitoring will continue to be leveraged in totality with remaining environmental and personnel
monitoring data and leveraged as part of final product disposition by the Quality Assurance Department.
To support this process change, RA-21-001-W, SOP LAB-007-W, SOP LAB-008-W, Operation and
Maintenance of the AES Sampl'Air Lite, and SOP LAB-041-W, Operation and Maintenance of the SAS Super
180 Microbial Air Sampler were revised. The effective date of these procedure revisions was 09Nov23.
Reference Exhibits O6-2, O6-3, O6-5 and O6-6.
Cleanroom and Microbiology personnel were trained on the relevant process changes and SOP revisions
starting on 09Nov23. SCA will not permit anyone to perform cleanroom duties or collect environmental
monitoring samples until all training requirements listed in all relevant responses have been completed.
OBSERVATION 6E RESPONSE
SCA has a robust environmental sampling plan in ISO 7 Compounding Rooms. Sampling within the ISO 7
Compounding Rooms is performed in risk-based sampling locations defined in RA-21-001-W and includes
viable and non-viable active air monitoring in addition to viable surface sampling of carts, tables, walls,
doors, and floors. Results generated are trended, assessed, and reported as per SOP LAB-030, Trend
Analysis of Environmental and Personnel Monitoring Results.
As part of process improvement, SCA has initiated change control MOC-2023-0130 to capture the
implementation of new sampling locations to include frequently contacted items such as cleanroom totes,
chairs, and repeater pumps. The results generated from these new locations will increase detectability
and provide an additional mechanism to assess aseptic technique/behavior within the classified area as
well as the effectiveness of the sanitization program. To support this process change, RA-21-001-W and
SOP LAB-007-W were revised and made effective on 09Nov23. Reference Exhibits O6-3 and O6-2.
Training for Cleanroom and Microbiology personnel on the relevant process changes and SOP revisions
began on 09Nov23. SCA will not permit anyone to perform cleanroom duties or collect environmental
monitoring samples until all training requirements listed in all relevant responses have been completed.
OBSERVATION 7
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate
design to facilitate operations for its intended use and cleaning and maintenance.
Specifically,
The firm uses polypropylene totes to transfer all compound materials from non-classified environments
into the ISO-7 compounding suite, which are further staged immediately adjacent to ISO-5 hoods. The
totes appeared to have scratches, and some were observed with UPC stickers, on the bottom side of the
tote and on lids, which appeared to be shedding. In addition, in July 2023, the firm performed a tote study
to determine bioburden found on the totes. Sampling results following the firm's standard sanitization
process and within the firm's ISO-7 environment found 3% of samples collected yielded microbial
recoveries. Of that, 60% were attributed to the genius Bacillus. Bacillus is a spore-forming bacterial
microbe.

- pharma
During the inspection, as an immediate containment action, the totes were evaluated, and any stickers
found were removed from totes and lids. SOP PICK-003-W, Picked Raw Material Verification Procedure,
was revised to include a requirement to ensure that no totes or tote lids have stickers. This procedure was
made effective on 23Oct23. Reference Exhibit O7-1.
SCA’s Quality Control Microbiology Department has performed an inspection and assessment of totes to
identify and remove from use in the cleanroom any that have evidence of scratches and/or damage. The
remaining, acceptable totes will be sanitized and prohibited from leaving the cleanroom. Per CAPA-2023-
0031, the new tote flow and inspection process, which will be ongoing, is established and is detailed in
SOP-SAN-002-W. This interim process will remain in place until new totes are obtained as per below.
SCA has placed orders to procure brand new cleanroom-dedicated totes. Once these totes are received,
the new tote flow will be applied per CAPA-2023-0031, and these cleanroom-dedicated totes will not be
permitted to leave the classified area and will also be inspected prior to use during material sanitization
(ongoing). Reference Exhibit O7-2. To support this process change, SOP SAN-002-W, Movement of
Materials Into and Out of Classified Areas, was revised per DAR-23-443 and was made effective on
09Nov23. Reference Exhibit O3-3.
In addition to purchasing new totes and dedicating them to the cleanroom, SCA has initiated change
control MOC-2023-0130 to capture the implementation of new sampling locations to include frequently
contacted items such as cleanroom totes, chairs, and repeater pumps.
Cleanroom personnel are being trained on the relevant process changes and SOP revisions starting on
10Nov23. SCA will not permit anyone to perform cleanroom duties until all training requirements have
been completed.
OBSERVATION 8
Procedures describing the handling of written and oral complaints related to drug products are deficiently
written or followed.
Specifically,
The firm failed to adequately investigate customer complaints. For example:
A. CUS-2023-0066, CUS-2023-0067, and CUS-2023-0068 were initiated on 25-Jul-23 regarding

suspected super potency and three patients who experienced loss of consciousness, lethargy and
inability to move, and issues moving legs, respectively, following administration of lot#
1223046077 (Fentanyl 2 mcg/mL and Ropivacaine HCl 0.2% in 0.9% Sodium Chloride 100 mL Bag).
The firm's investigation stated the complaints were not able to be confirmed; however, the firm
failed to test returned products which were identified as integral. The investigation was approved
and closed by Quality Assurance 25-AUG-23, 23-AUG-23, and 28-AUG-23 respectively.
B. CUS-2021-0051 (AE-21-009-W and AE-21-010-W) were initiated on 24-May-21 regarding

suspected super potency and two patients who experienced severe decrease in heart rate and
QRS complexes, respectively, following administration of lot# 1221027041 (Phenylephrine HCl
l00mcg/mL in 0.9% Sodium Chloride 10 mL fill 12 mL Syringe). The firm's investigation stated the

- pharma
complaints were not able to be confirmed; however, the firm failed to test returned products. The
investigation was approved and closed by Quality Assurance 30-JUN-21.
SCA has revised SOP QMS-013, Handling of Customer Complaints and Adverse Events, per DAR-23-493 to
require testing of unused returned product associated with adverse events. This procedure was made
effective on 04Nov23. Reference Exhibit O8-1.
SCA also reviewed all open adverse events that were being investigated at the time of this response. Of
those open adverse events, one open adverse event was identified to have had product returned and
within expiry. Therefore, SCA tested returned samples for adverse event CUS-2023-0090 on 30Oct23 with
satisfactory results. Reference Exhibit O8-2. SCA notes that the product lots specifically identified in the
Agency’s Observation were expired and therefore not tested.
OBSERVATION 9
Appropriate controls are not exercised over computers or related systems to assure that changes in
master production and control records or other records are instituted only by authorized personnel.
Specifically,
A. Partially completed original GMP documents including but not limited to laboratory sheets and
stability study sheets were found in the firm's shred bins. The firm's procedure, SOP QA000l -
Good Documentation Practices, prohibits this practice.
B. Multiple copies of blank fillable original GMP documents including but not limited to sterility
worksheets and additional laboratory worksheets were found in the firm's shred bins. The firm
maintains GMP documents in MasterControl QMIS which allows authorized personnel to
download documents to individual computer terminals with a 24-hour restriction; however, there
are no restrictions on the number of copies that can be printed.
SCA has conducted employee interviews relating to placing documents in shred bins. There was no
evidence of ill intent, and SCA’s investigation has not identified any action taken to obscure test data or
results. In response to FDA’s observation, SCA initiated DEV-2023-0478 and performed an immediate
awareness training between 25Sep23 and 28Sep23 with the staff in the area where the incident was first
discovered. Reference Exhibit O9-1. Additionally, on 28Sep23, the SCA leadership team distributed a
company-wide awareness communication for GDP principles highlighted in SOP QA-001, Good
Documentation Practices, and SOP QMS-002, Quality Record Issuance and Retention. Reference Exhibit
O9-2.
Additional process improvements include:
• On 27Sep23, SCA initiated CAPA-2023-0020, “Remediation of GxP Document Retention

Practices.” As part of this CAPA, the following corrective actions have/will be implemented:

- pharma
o SOP QA-001, Good Documentation Practices, was revised per DAR-21-708 to prohibit the
destruction of any official controlled documents that have been completed, partially
completed, or transcribed and to reference a new visual display, VD QA-001-1, Shred Bin
Signage, to be displayed on the front of each shred bin. This SOP revision and associated
Visual Display were made effective on 28Sep23. The visual display was placed on the front of
each shred bin in the facility. All SCA personnel were trained on the revised SOP. Reference
Exhibit O9-3, O9-4 and O9-5 for revised SOP, Visual Display, and training record.
o SOP QMS-002, Quality Record Issuance and Retention, was revised per DAR-23-466 to
specifically require retention of controlled forms that have been uploaded into MasterControl
records. The procedure became effective on 28Sep23. Reference Exhibit O9-6.
o On 02Oct23, Quality Management began performing scheduled shred bin checks. SOP QA-
020, Quality Oversight, was revised per DAR-23-461 to require monthly shred bin checks. This
procedure became effective on 08Nov23. Reference Exhibit O9-7. This check is documented
on LG QA-020-1-W, 1st Shift MQA Reconciliation Log and LG QA-020-2-W, 2nd Shift MQA
Reconciliation Log. Reference Exhibits O9-8 and O9-9.
o SOP QMS-046, Document Shredding Policy, was created per DAR-23-464. This procedure
details the proper and improper use of shred bins, including process surrounding destruction
of forms used for training purposes only, and was made effective on 10Nov23. Reference
Exhibit O9-10.
o A process surrounding use of controlled forms for training only purposes will also be
incorporated into SOP QMS-001, Controlled Document Management and Change Control and
SOP QMS-002 in conjunction with the corrective actions described in Observation 9B. The
target completion date for this process implementation is 31Dec23.
Process improvements include:
• SCA will begin to restrict printing access to all GMP documents that are currently printed from
MasterControl and intended for entry of GMP raw data. All applicable documents have been
evaluated and will be controlled in one of three ways:
o Batch-related forms that can be issued through the existing batch record issuance process
detailed in SOP LGEN-001, Generating the Batch Record, Tote Tags, and Test Sample Tags,
will begin being issued as part of that process.
o Forms that can be bound will be converted into logbooks and issued/controlled per SOP
QMS-040, Documentation and Handling of Logbooks and Laboratory Notebooks.
o Documents that cannot be issued with the batch record, bound as a logbook, or converted
into electronic forms will be individually issued by the Quality Unit.
SOP QMS-001, Controlled Document Management and Change Control and SOP QMS-002, Quality Record
Issuance and Retention, will be revised per DAR-23-510 to describe the process for controlling fillable
documents. Upon these document revisions becoming effective, printing access to all fillable GMP
documents in MasterControl will be restricted to individuals in the Quality unit who are authorized to
issue documents. The expected completion date of this process change is 31Dec23.

- pharma
As a long-term process enhancement, SCA will implement use of the LabVantage Laboratory Execution
System (LES) Module, which will allow for digitization of all laboratory forms with a complete audit trail.
MOC-2023-0135 was initiated on 06Nov23 and the target completion date is 31Jul24.
OBSERVATION 10
The labels of your outsourcing facility's drug products do not include information required by section
503B(a)(IO)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Specifically,
Some of your drug product labels did not include the complete established name of the drug product, as
the established name did not include the name of the salt (e.g., citrate, bitartrate, and hydrochloride) in
addition to the base on the label.
For example,
A. Fentanyl 100 mcg/2 mL. The label does not include the full name Fentanyl Citrate.
B. Norepinephrine 4 mg in 0.9% Sodium Chloride 250 mL bag. The label does not include the full
name Norepinephrine Bitartrate.
C. Ketamine 100 mg/10 mL does not include the full name Ketamine HCL (Hydrochloride).
SCA initiated change control MOC-23-0109 on 28Sep23 to update the Fentanyl Citrate and Ketamine HCl
products identified by the Agency that do not bear the complete established name of the drug product
which includes the name of the salt and/or base. An additional change control, MOC-2023-0110, was
initiated on 29Sep23 to update the products self-identified by SCA to also be impacted. The target
completion date for the aforementioned change controls is 24May24.

- pharma
COMMITMENT INDEX (ORGANIZED BY OBSERVATION NUMBER)

Date Completed/
Observation Exhibit Quality System
Response Action Status Projected
Number Number Reference
Completion Date
O1 Initiate Recall 23-004-W. N/A Recall 23-004-W Complete 09Nov23
Complete CAPA-2022-0034 to implement a remediation plan for the
O1 N/A CAPA-2022-0034 In-Process 23Jun24
identified inspection improvements.
Close MOC-2023-0129 related to implementation of the remediated
O1 N/A MOC-2023-0129 In-Process 30Nov23
inspection process.
O1 Revise SOP ILP-001-W, Product Inspection and Defect Classification. O1-4 DAR-23-271 Complete 09Nov23
O2 Begin training on SOP ILP-001-W revisions. N/A N/A In-Process Started: 09Nov23
O1 Revise the twelve forms associated with SOP ILP-001-W. O1-5 DAR-23-521 Complete 09Nov23
O2 Revise SOP ILP-001-W, Product Inspection and Defect Classification. O1-4 DAR-23-271 Complete 09Nov23
O2 Begin training on SOP ILP-001-W revisions. N/A N/A In-Process Started: 09Nov23
O3A Revise TM-008, Particulate Matter. O3-2 DAR-23-511 Complete 06Nov23
O3B Close CAPA-2023-0017 related to the material sanitization improvements. N/A CAPA-2023-0017 In-Process 30Nov23
Revise SOP SAN-002-W, Movement of Materials into and out of Classified
O3B O3-3 DAR-23-443 Complete 10Nov23
Areas.
O3B Begin training on SOP SAN-002-W revisions. N/A N/A In-Process Started: 10Nov23
O3B Create sanitization training videos. N/A N/A Complete 08Nov23
O3B Begin training on sanitization training videos. N/A N/A In-Process Started: 10Nov23
O3B Complete DEV-2023-0435. O3-4 DEV-2023-0435 Complete 26Oct23

- pharma

Date Completed/
Completion Date
O3C Revise SOP QA-014, Foreign Material Decision Matrix. O3-5 DAR-23-520 Complete 09Nov23
O3C Create VD QA-014-2, Visual Display for Defect Examples. O3-6 DAR-23-520 Complete 09Nov23
Start Date:
O3C Begin training on SOP QA-014 and VD QA-014-2 revisions. N/A N/A In-Process
13Nov23
O3C Revise Form QA-014-1, Foreign Material Documentation Form. O3-7 DAR-23-520 Complete 09Nov23
O3C Revise TQ COM-100-2-W, Aseptic Assistant Technical Qualification. O3-8 DAR-23-527 Complete 09Nov23
SUP-2023-0026
O3C Initiate Supplier Complaints for each syringe tray supplier. N/A SUP-2023-0027 Complete 10Oct23
SUP-2023-0028
O3C Send out escalation letters to syringe tray suppliers. N/A N/A In-Process 13Nov23
O4A O3-3 DAR-23-443 Complete 10Nov23
Areas.
O3A Begin training on SOP SAN-002-W revisions. N/A N/A In-Process Started: 10Nov23
O4A Revise SOP SAN-001-W, Cleaning of Classified Areas. O4-1 DAR-23-508 Complete 10Nov23
O4A Begin training on SOP SAN-001-W revisions. N/A N/A In-Process Started: 10Nov23
Complete ES-23-026, Engineering Study for the Efficacy of Wipe Preparation
O4A N/A ES-23-026 In-Process 30Nov23
and Cleaning of Cleanroom Materials and Equipment.
Complete VAL-23-074, Cleaning Qualification of Prepared Sanitization Wipes
O4A N/A VAL-23-074 In-Process 31Dec23
on Cleanroom Materials and Equipment.
Re-Train material sanitization department on requirement for totes to
O4B O4-2 N/A Complete 04Oct23
achieve prescribed contact time per SOP SAN-002-W.

- pharma

Date Completed/
Completion Date
Areas.
O4B Begin training on SOP SAN-002-W revisions. N/A N/A In-Process Started: 10Nov23
O4C Perform EA-23-027, Engineering Study for Grate Cleaning Frequency N/A N/A In-Process 31Jan24
O5A Training of Compounding staff on SOP COM-001-W and SOP SAN-002-W. O5-1 N/A Complete 01Nov23
O5A Retrain Operator PJ on SOP COM-001-W. O5-2 N/A Complete 19Sep23
O5A Revise SOP COM-018-W, Staging of Raw Material in the LAFH. O5-3 DAR-23-531 Complete 09Nov23
O5A Begin training on SOP COM-018-W revisions. N/A N/A In-Process Started: 10Nov23
O5A Close CAPA-2023-0028 related to aseptic technique. N/A CAPA-2023-0028 In-Process 22Dec23
O5A Revise SOP COM-061-W, Roles and Responsibilities of Cleanroom Personnel. O5-4 DAR-23-512 Complete 09Nov23
O5A Perform training on SOP COM-061-W revisions. N/A N/A In-Process Started: 10Nov23
O5A Revise SOP LAB-074-W, Microbiology Oversight of Critical Areas O5-5 DAR-23-516 Complete 09Nov23
O5A Perform training on SOP LAB-074-W revisions. N/A N/A In-Process Started: 10Nov23
O5A Create “Micro 101” Training for all gowning qualified personnel. O5-6 TRNDoc-0056 Complete 08Nov23
O5A Perform “Micro 101” Trainings. N/A N/A In-Process Started: 10Nov23
O5A Create “Cleanroom 101” Training all gowning qualified personnel. O5-7 TRNDoc-0055 Complete 08Nov23

- pharma

Date Completed/
Completion Date
O5A Perform “Cleanroom 101” Training. N/A N/A In-Process Started: 10Nov23
O5A Complete MOC-2023-0137 to convert paper tote tags to disposable tote tags. N/A MOC-2023-0137 In-Process 29Feb24
Complete MOC-2023-0142 to implement a process to autoclave batch
O5A N/A MOC-2023-0142 In-Process 29Feb24
records.
O5B Training of Compounding staff on SOP COM-001-W and SOP SAN-002-W. O5-1 N/A Complete 02Nov23
O5B Revise SOP COM-005-W, Compounding Area Clearance. O5-8 DAR-23-512 Complete 09Nov23
O5B Revise LG COM-005-1-W, Compounding Area and Equipment Use Log. O5-9 DAR-23-512 Complete 09Nov23
O5B Perform training on SOP COM-005-W and LG COM-005-1-W revisions. N/A N/A In-Process Started: 10Nov23
O5B Revise SOP COM-061-W, Roles and Responsibilities of Cleanroom Personnel. O5-4 DAR-23-512 Complete 09Nov23
O5B Perform training on SOP COM-061-W revisions. N/A N/A In-Process Started: 10Nov23
Areas.
O5B Perform training on SOP SAN-002-W revisions. N/A N/A In-Process Started: 10Nov23
Close MOC-2023-0130 regarding the implementation of new sampling
06A N/A MOC-2023-0130 In-Process 31Jan24
locations within the classified areas
Close MOC-2023-0131 regarding aseptic assistant’s glove recovery results
O6A N/A MOC-2023-0131 In-Process 31Jan24
batch release criteria.
Revise SOP LAB-007-W, Environmental and Personnel Monitoring of Classified
Areas.
O6A Perform training SOP LAB-007-W revisions. N/A N/A In-Process Started: 10Nov23

- pharma

Date Completed/
Completion Date
Revise RA-21-001-W, Risk Assessment for Controlled Environments located at
755 Rainbow Rd, Windsor, CT 06095.
O6B Revise SOP COM-018-W, Staging of Raw Material in the LAFH. O5-3 DAR-23-531 Complete 09Nov23
O6B Perform training on SOP COM-018-W revisions. N/A N/A In-Process Started: 10Nov23
Areas.
O6B Perform training SOP LAB-007-W revisions. N/A N/A In-Process Started: 10Nov23
Revise SOP LAB-030, Trend Analysis of Environmental and Personnel
O6B N/A DAR-23-528 In-Process 30Nov23
Monitoring Results.
Perform an independent third-party assessment of each unique bacterial
O6C spore forming genus and species recovered between January 2020 and O6-4 N/A Complete 30Oct23
September 2023.
Revise SOP LAB-030, Trend Analysis of Environmental and Personnel
O6C N/A DAR-23-528 In-Process 30Nov23
Monitoring Results.
Close MOC-2023-0132 regarding the improvement and optimization of active
O6D N/A MOC-2023-0132 In-Process 31Jan24
viable air sampler positioning.
O6D O6-2 DAR-23-542 Complete 09Nov23
Areas.
O6D Perform training SOP LAB-007-W revisions. N/A N/A In-Process Started: 10Nov23
O6D Revise SOP LAB-008-W, Operation and Maintenance of the AES Sampl'Air Lite. O6-5 DAR-23-519 Complete 09Nov23

- pharma

Date Completed/
Completion Date
O6D Perform training on SOP LAB-008-W revisions. N/A N/A In-Process Started: 10Nov23
Revise SOP LAB-041-W, Operation and Maintenance of the SAS Super 180
Microbial Air Sampler.
O6D Perform training on SOP LAB-041-W revisions. N/A N/A In-Process Started: 10Nov23
06E N/A MOC-2023-0130 In-Process 31Jan24
locations within the classified areas.
O6E O6-2 DAR-23-542 Complete 09Nov23
Areas.
O6E Perform training SOP LAB-007-W revisions. N/A N/A In-Process Started: 10Nov23
O6E O6-3 DAR-23-542 Complete 09Nov23
O7 Close CAPA-2023-0017 related to the material sanitization improvements. N/A CAPA-2023-0017 In-Process 30Nov23
O7 Revise SOP PICK-003-W, Picked Raw Material Verification Procedure. O7-1 DAR-23-471 Complete 23Oct23
O7 Perform training on SOP PICK-003-W revisions. N/A N/A In-Process Started: 10Nov23
O7 Complete CAPA-2023-0031 regarding the implementation of a new tote flow. N/A CAPA-2023-0031 In-Process 31Jan23
O7 Revise process flow of cleanroom totes. O7-2 N/A Complete 10Nov23

Revise SOP SAN-002-W, Movement of Materials Into and Out of Classified
O7 O3-3 DAR-23-443 Complete 10Nov23
Areas.
O7 Perform training on SOP SAN-002-W revisions. N/A N/A In-Process Started: 10Nov23
Re-Train material sanitization department on requirement for totes to
O7 O4-2 N/A Complete 04Oct23
achieve prescribed contact time per SOP SAN-002-W.

- pharma

Date Completed/
Completion Date
07 N/A MOC-2023-0130 In-Process 31Jan24
locations within the classified areas.
O8 Revise SOP QMS-013, Handling of Customer Complaints and Adverse Events. O8-1 DAR-23-493 Complete 04Nov23
O8 Complete CUS-2023-0090. O8-2 CUS-2023-0090 Complete 05Nov23

Perform immediate awareness training with the staff where the incident was 25Sep23
O9 O9-1 N/A Complete
first discovered. 28Sep23
Send out awareness communication for GDP principles highlighted in SOP
O9 O9-2 N/A Complete 28Sep23
QA-001 and SOP QMS-002.
O9 Complete CAPA-2023-0020 to remediate GxP document retention practices. N/A CAPA-2023-0020 In-Process 30Jan23
O9 Revise SOP QA-001, Good Documentation Practices. O9-3 DAR-21-708 Complete 28Sep23
O9 Create VD QA-001-1, Shred Bin Signage. O9-4 DAR-21-708 Complete 28Sep23
O9 Revise SOP QMS-002, Quality Record Issuance and Retention. O9-6 DAR-23-466 Complete 28Sep23
O9 Revise SOP QA-020, Quality Oversight. O9-7 DAR-23-461 Complete 08Nov23
O9 Create SOP QMS-046, Document Shredding Policy. O9-10 DAR-23-464 Complete 10Nov23
Develop a process surrounding use of controlled forms for training only
O9 N/A N/A In-Process 31Dec23
purposes.
Revise SOP QMS-001, Controlled Document Management and Change
O9 N/A DAR-23-510 In-Process 31Dec23
Control.
O9 Revise SOP QMS-002, Quality Record Issuance and Retention. N/A DAR-23-510 In-Process 31Dec23
Complete MOC-2023-0135 regarding the implementation of LabVantage
O9 N/A MOC-2023-0135 In-Process 31Jul24
Laboratory Execution System (LES) Module.

- pharma

Date Completed/
Completion Date
Complete MOC-2023-0109 regarding updating labels that do not bear the
O10 complete established name of the drug product which includes the name of N/A MOC-2023-0109 In-Process 24May24
the salt and/or base.
Complete MOC-2023-0110 regarding updating additional self-identified labels
O10 that do not bear the complete established name of the drug product which N/A MOC-2023-0110 In-Process 24May24
includes the name of the salt and/or base.

- pharma
EXHIBIT MATRIX (ORGANIZED BY OBSERVATION NUMBER)

Observation Exhibit
Title Pages
Number Number
O1 O1-1 MAN-001, Quality Manual 19
O1 O1-2 SOP QMS-027, Responsibilities of the Quality Unit 11
O1 O1-3 Consultant’s Schedule 7
O1/O2 O1-4 SOP ILP-001-W, Product Inspection and Defect Classification 35
Twelve (12) Forms associated with SOP ILP-001:
Form ILP-001-4-W, ILP Signature Log and Bag 100% Inspection Form
Form ILP-001-5-W, Bag AQL Inspection Form
Form ILP-001-6-W, Bag Additional 100% Inspection Form
Form ILP-001-7-W, Bag TAQL Inspection Form
Form ILP-001-8-W, ILP Signature Log and Syringe 100% Inspection Form
O1 O1-5 Form ILP-001-9-W, Syringe AQL Inspection Form 15
Form ILP-001-10-W, Syringe Additional 100% Inspection Form
Form ILP-001-11-W, Syringe TAQL Inspection Form
Form ILP-001-12-W, ILP Signature Log and CADD 100% Inspection Form
Form ILP-001-13-W, CADD AQL Inspection Form
Form ILP-001-14-W, CADD Additional 100% Inspection Form
Form ILP-001-15-W, CADD TAQL Inspection Form
O3A O3-1 USP <788> 4
O3A O3-2 TM-008, Particulate Matter 15
O3B/O4A/O4B
O3-3 SOP SAN-002-W, Movement of Materials into and out of Classified Areas 27
/O7
O3B O3-4 DEV-2023-0435 72

O3C O3-5 SOP QA-014, Foreign Material Decision Matrix 5
O3C O3-6 VD QA-014-2, Visual Display for Defect Examples 5
O3C O3-7 Form QA-014-1, Foreign Material Documentation Form 1
O3C O3-8 TQ COM-100-2-W, Aseptic Assistant Technical Qualification 18
O4A O4-1 SOP SAN-001-W, Cleaning of Classified Areas 25
O4B/O3B/O7 O4-2 Material sanitization department contact time retraining 2
O5A/O5B O5-1 Training of Compounding staff on SOP COM-001-W and SOP SAN-002-W 4
O5A O5-2 Retraining of PJ on Aseptic Behavior 1
O5A/O6B O5-3 SOP COM-018-W, Staging of Raw Material in the LAFH 15
O5A/O5B O5-4 SOP COM-061-W, Roles and Responsibilities of Cleanroom Personnel 13

- pharma

Observation Exhibit
Title Pages
Number Number
O5A O5-5 SOP LAB-074-W, Microbiology Oversight of Critical Areas 8
O5A O5-6 “Micro 101” Training Presentation 18
O5A O5-7 “Cleanroom 101” Training Presentation 19
O5B O5-8 SOP COM-005-W, Compounding Area Clearance 5
O5B O5-9 LG COM-005-1-W, Compounding Area and Equipment Use Log 100
O6A O6-1 Media Fill Results Table 3
O6A/O6B/O6D SOP LAB-007-W, Environmental and Personnel Monitoring of Classified
O6-2 27
O6E Areas
O6A/O6B/O6D RA-21-001-W, Risk Assessment for Controlled Environments located at

O6-3 95
O6E 755 Rainbow Rd, Windsor, CT 06095
Independent third-party assessment of each unique bacterial spore

O6C O6-4 forming genus and species recovered between January 2020 and 23
September 2023 for risk to patient
O6D O6-5 SOP LAB-008-W, Operation and Maintenance of the AES Sampl'Air Lite 12
SOP LAB-041-W, Operation and Maintenance of the SAS Super 180
O6D O6-6 11
Microbial Air Sampler
O7 O7-1 SOP PICK-003-W, Picked Raw Material Verification Procedure 6
O7 O7-2 Process flow of cleanroom totes 1
O8 O8-1 SOP QMS-013, Handling of Customer Complaints and Adverse Events 35
O8 O8-2 CUS-2023-0090 134
Immediate awareness training with the microbiology staff where the
O9 O9-1 3
incident was first discovered.
Awareness communication for GDP principles highlighted in SOP QA-001
O9 O9-2 1
and SOP QMS-002
O9 O9-3 SOP QA-001, Good Documentation Practices 10
O9 O9-4 VD QA-001-1, Shred Bin Signage 1
O9 O9-5 Training on SOP QA-001 12
O9 O9-6 SOP QMS-002, Quality Record Issuance and Retention 7
O9 O9-7 SOP QA-020, Quality Oversight 6

- pharma

Observation Exhibit
Title Pages
Number Number
O9 O9-8 LG QA-020-1-W, 1st Shift MQA Reconciliation Log 56
O9 O9-9 LG QA-020-2-W, 2nd Shift MQA Reconciliation Log 55
O9 O9-10 SOP QMS-046, Document Shredding Policy 5

483 Response of SCA

Uploaded by

Copyright:

Available Formats

483 Response of SCA

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

483 Response of SCA

Uploaded by

Copyright:

Available Formats

DocuSign Envelope ID: EB22856B-7133-40AD-87C4-99A0C1AACECD

November 10, 2023

Dear Ms. Harlan,

We look forward to the close-out of this inspection and issuance of an EIR.

There is no quality control unit.

C. In addition, your visual inspection process is deficient. For example:

SCA CONFIDENTIAL Page 2 of 33

SCA CONFIDENTIAL Page 3 of 33

SCA CONFIDENTIAL Page 4 of 33

SCA CONFIDENTIAL Page 5 of 33

These products have been released and distributed.

For example: Out of Specification (OOS-2023-0069) initiated on or about 29-Aug-2023 identified

SCA CONFIDENTIAL Page 6 of 33

SCA CONFIDENTIAL Page 7 of 33

SCA CONFIDENTIAL Page 8 of 33

Reference the response to Observation 1.

SCA CONFIDENTIAL Page 9 of 33

SCA CONFIDENTIAL Page 10 of 33

SCA CONFIDENTIAL Page 11 of 33

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile

SCA CONFIDENTIAL Page 12 of 33

Additional corrective actions and process improvements include:

SCA CONFIDENTIAL Page 13 of 33

Additional process improvements include:

SCA CONFIDENTIAL Page 14 of 33

SCA CONFIDENTIAL Page 15 of 33

SCA CONFIDENTIAL Page 16 of 33

SCA CONFIDENTIAL Page 17 of 33

SCA CONFIDENTIAL Page 18 of 33

The firm failed to adequately investigate customer complaints. For example:

A. CUS-2023-0066, CUS-2023-0067, and CUS-2023-0068 were initiated on 25-Jul-23 regarding

B. CUS-2021-0051 (AE-21-009-W and AE-21-010-W) were initiated on 24-May-21 regarding

SCA CONFIDENTIAL Page 19 of 33

Additional process improvements include:

• On 27Sep23, SCA initiated CAPA-2023-0020, “Remediation of GxP Document Retention

SCA CONFIDENTIAL Page 20 of 33

Process improvements include:

SCA CONFIDENTIAL Page 21 of 33

SCA CONFIDENTIAL Page 22 of 33

COMMITMENT INDEX (ORGANIZED BY OBSERVATION NUMBER)

O3A Revise TM-008, Particulate Matter. O3-2 DAR-23-511 Complete 06Nov23

O3B Create sanitization training videos. N/A N/A Complete 08Nov23

O3B Complete DEV-2023-0435. O3-4 DEV-2023-0435 Complete 26Oct23

SCA CONFIDENTIAL Page 23 of 33

COMMITMENT INDEX (ORGANIZED BY OBSERVATION NUMBER)

SCA CONFIDENTIAL Page 24 of 33

COMMITMENT INDEX (ORGANIZED BY OBSERVATION NUMBER)

O5A Retrain Operator PJ on SOP COM-001-W. O5-2 N/A Complete 19Sep23

SCA CONFIDENTIAL Page 25 of 33

COMMITMENT INDEX (ORGANIZED BY OBSERVATION NUMBER)

SCA CONFIDENTIAL Page 26 of 33

COMMITMENT INDEX (ORGANIZED BY OBSERVATION NUMBER)

SCA CONFIDENTIAL Page 27 of 33

COMMITMENT INDEX (ORGANIZED BY OBSERVATION NUMBER)

O7 Revise process flow of cleanroom totes. O7-2 N/A Complete 10Nov23

SCA CONFIDENTIAL Page 28 of 33

COMMITMENT INDEX (ORGANIZED BY OBSERVATION NUMBER)

O8 Complete CUS-2023-0090. O8-2 CUS-2023-0090 Complete 05Nov23

O9 Create VD QA-001-1, Shred Bin Signage. O9-4 DAR-21-708 Complete 28Sep23