Foreign Supplier Verification Programs for Importers of Food

for Humans and Animals (FSVP) Regulation Records Requirements

This list of records required by the FSVP regulation, including a record referred to as a
document, documentation, and written procedures, is organized into:
FSVP Records - Standard Requirements 21 CFR
1.502, 1.504, 1.505, 1.506, 1.508, 1.509, 1.510

FSVP Records -Modified Requirements

21 CFR 1.507, 1.511, 1.512, 1.513

Additional information on the FSVP regulation is available on FDA’s FSVP web page.
_________________________________________________________________________________

FSVP Records - Standard Requirements

21 CFR 1.502, 1.504, 1.505, 1.506, 1.508, 1.509, 1.510

Section 1.502 - What foreign supplier verification program (FSVP) must I have?

Unless exempt, all importers of human and animal food must develop, maintain, and follow
an FSVP for each food and foreign supplier (1.502(a)). (See enforcement policies: Policy
Regarding Certain Entities Subject to the Current Good Manufacturing Practice and
Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs;
Application of the Foreign Supplier Verification Program Regulation to the Importation of
Live Animals; Application of the Foreign Supplier Verification Program Regulation to
Importers of Grain Raw Agricultural Commodities; and Enforcement Policy for Entities
Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds)

Records: Importer of LACF (1.502(b)(1)):

 FSVP (not required to address microbiological hazards controlled by 21 CFR part 113 in
LACF). See records requirements below for specific applicable sections of the FSVP
regulation.
 Foreign supplier’s compliance with 21 CFR part 113

Records: Importer is LACF manufacturer/processor (1.502(b)(1)):

 FSVP (not required to address microbiological hazards in raw materials and ingredients
used to manufacture/process LACF if controlled by 21 CFR part 113). See records
requirements below for specific applicable sections of the FSVP regulation.

Records: Importer is subject to section 418 of FD&C Act (preventive controls) (1.502(c)):
 An importer who is also a manufacturer and is subject to both FSVP and the supply
chain program provisions of either the human food or animal food preventive controls
regulation (21 CFR 117 subpart G or 21 CFR part 507 subpart E, respectively) may
choose to be in compliance with the applicable preventive controls regulation or with
FSVP. If the importer chooses to comply with the supply chain provisions of the
applicable preventive controls regulation, they are not required to have an FSVP, except
must comply with section 1.509.
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 Foreign Supplier Verification Programs for Importers of Food for Humans and
Animals (FSVP) Regulation Records Requirements

Section 1.504 – What hazard analysis must I conduct?

Records: Hazard Analysis

 Hazard analysis
 Hazard identification
 Analysis of known or reasonably foreseeable hazards in each food:
> Biological, chemical, and physical hazards
> Foreseeable hazards that may be present in a food because (i) hazard occurs
naturally; (ii) hazard may be unintentionally introduced; or (iii) hazard may be
intentionally introduced for purposes of economic gain.
 Hazard evaluation
 Evaluation of identified hazards to assess probability that hazard will occur in the
absence of controls and the severity of the illness or injury if the hazard were to
occur
 Evaluation of environmental pathogens when a ready-to-eat food is exposed to
the environment before packaging and the packaged food does not receive a
treatment or otherwise include a control or measure
> Consideration of effect of relevant factors on the safety of the finished food for the
intended consumer, including: (i) formulation; (ii) condition, function, and design
of the establishment and equipment of a typical entity that
manufactures/processes, grows, harvests, or raises this type of food; (iii) raw
materials and other ingredients; (iv) transportation practices; (v) harvesting,
raising, manufacturing, processing, and packing procedures; (vi) packaging and
labeling activities; (vii) storage and distribution; (viii) intended or reasonably
foreseeable use; and (ix) sanitation, including employee hygiene factors.
 Hazard analysis performed by qualified individual
OR
Records: Hazard Analysis
 Review and assessment of another entity’s hazard analysis
 Include documentation that qualified individual conducted the hazard analysis

Records: Reevaluation
 Reevaluation of the foreign supplier’s performance and risks posed by the food.
(Reevaluation if importer obtains new information or concerns relating to foreign supplier
or at the end of any 3-year period)
 Actions taken or changes to FSVP based on reevaluation (e.g., discontinue use of
foreign supplier, change verification activities)
OR
Records: Reevaluation
 Review and assessment of the other entity’s documentation or reevaluation
 Include documentation that qualified individual conducted the hazard analysis
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Section 1.505 – What evaluation for foreign supplier approval and verification must I
conduct?

Records: Evaluation of foreign supplier’s performance and risk posed by food

 Document the evaluation of foreign supplier’s performance and risk posed by the food
 Approval of foreign supplier, based on evaluation of foreign supplier’s performance and
risk posed by food
> Consideration of appropriate and necessary factors, including: (i) hazard analysis,
including nature of the hazard requiring a control; (ii) entity or entities that will
significantly minimize or prevent hazards requiring a control or verifying that hazards
have been significantly minimized or prevented; and (iii) foreign supplier
performance
 Reevaluation of supplier approval based on new information relating to factors used as
basis for approval, or at least every three years. If concerns relating to importing food
from a foreign supplier change, including:
> Determination of whether it is appropriate to continue to import the food from the
foreign supplier
> Determination of whether supplier verification activities need to be changed
> Any actions taken based on results of reevaluation
OR
Records: Evaluation of foreign supplier’s performance and risk posed by food
 Review and assessment of another entity’s evaluation or reevaluation of risk posed by
the food and performance of the foreign supplier, including:
> Evaluation or reevaluation performed by qualified individual
_________________________________________________________________________

Section 1.506 - What foreign supplier verification and related activities must I
conduct?

Records: Importer develops procedures for importing food only from approved foreign
suppliers or importer conducts review and assessment of procedures established by
another entity for importing food only from approved foreign suppliers
 Procedures for importing food only from approved foreign suppliers
OR
 Review and assessment of procedures established by another entity for importing food
only from approved foreign suppliers

 Use of procedures for importing food from approved suppliers

Records: Importer develops procedures for importing food from unapproved foreign
suppliers or importer conducts review and assessment of procedures established by
another entity for importing food from unapproved foreign suppliers
 Procedures for importing food from unapproved foreign suppliers, when necessary and
appropriate
OR

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 Foreign Supplier Verification Programs for Importers of Food for Humans and
Animals (FSVP) Regulation Records Requirements

 Review and assessment of procedures established by another entity for importing food
from unapproved foreign suppliers when necessary and appropriate

 Use of procedures for importing food from unapproved suppliers

 Procedures for ensuring appropriate verification activities conducted
 Determination of supplier verification activities that will be conducted, including:
> Frequency of conducting activity
> Entity or entities significantly minimizing or preventing hazard or verifying hazards
significantly minimized or prevented
> If SAHCODHA hazard, determination that less frequent auditing or alternate
verification activity is appropriate rather than an initial and annual onsite audit
OR
 Review and assessment of another entity’s determination of appropriate supplier
verification activities, including:
> Other entity’s determination is appropriate, including frequency
> Determination made by qualified individual
Records: Performance of one or more foreign supplier verification activities
 Onsite audit
> Include audit procedures, audit dates, conclusions, corrective actions, performed by
qualified auditor
o If the food is subject to one or more FDA food safety regulations, must consider
applicable FDA food safety regulations or, when applicable, may consider
relevant laws and regulations of country whose food safety system FDA has
officially recognized as comparable or determined to be equivalent to that of the
United States
o Must include review of supplier’s written food safety plan, if any, and its
implementation, for the hazard being controlled
> Conducted before importing the food and periodically thereafter
> Must be performed by entity other than foreign supplier
> Results of inspection can be substituted for onsite audit (inspection within 1 year of
date audit would have been conducted)
 Sampling and testing of the food
> Include number of samples tested, type of tests conducted, dates of tests, date of
test report, results, any corrective actions, testing laboratory, performed by qualified
individual
> Conducted before importing the food and periodically thereafter
 Review foreign supplier’s food safety records
> Include dates, general nature of records reviewed, conclusions, any corrective
actions taken, conducted by qualified individual
> Cannot be performed by foreign supplier
> Conducted before importing the food and periodically thereafter
 “Other” verification activity - Conduct and document or obtain documentation of other
supplier verification activity

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 Foreign Supplier Verification Programs for Importers of Food for Humans and
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> Documentation of each activity, including description of activity, date activity

conducted, findings or results, any corrective actions taken, and conducted by
qualified individual
> Conducted before importing the food and periodically thereafter
OR
 Review and assessment of results of supplier verification activity performed by another
entity
> Documentation that appropriate supplier verification conducted for each foreign
supplier before importing the food and periodically thereafter
> Actions taken if results of verification activity do not provide adequate assurance that
hazards requiring a control in the food were significantly minimized or prevented
> Foreign supplier itself or its employees may not perform supplier verification
activities, except with respect to sampling and testing of food
> Not required to retain documentation of verification activity conducted by another
entity, but must obtain the documentation and make it available to FDA upon request
_________________________________________________________________________

Section 1.508 – What corrective actions must I take under my FSVP?

 Corrective actions taken (if applicable)

 Investigations (if applicable)
 FSVP modifications (if applicable)
_________________________________________________________________________

Section 1.509 – How must the importer be identified at entry?

 Importer identification information provided electronically when filing entry with CBP
 Before food is imported or offered for import, if no U.S. owner or consignee, importer
designated a U.S. agent or representative as the importer
_________________________________________________________________________

Section 1.510 – How must I maintain records of my FSVP?

 Records kept as original records, true copies (such as photocopies, pictures, scanned
copies, microfilm, microfiche, or other accurate reproductions of the original records), or
electronic records
> May use existing records that contain all required FSVP information or may
supplement existing records as necessary to include all required information.
> Required FSVP information need not be maintained as one set of records (i.e., new
FSVP information may be maintained separately or combined with existing records)
 Records signed and dated upon initial completion and any modification
 Records legible and stored to prevent deterioration or loss
 Records available promptly to authorized FDA representative, upon request, for
inspection and copying
 English translation provided within a reasonable time, upon FDA request
 Records stored offsite retrieved and provided onsite within 24 hours of FDA request.
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 Foreign Supplier Verification Programs for Importers of Food for Humans and
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 Records sent to Agency electronically, or through another means that delivers the
records promptly, upon written FDA request
 Records retained until at least 2 years after created or obtained, or records related to
processes and procedures retained for at least 2 years after their use was discontinued.
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 Foreign Supplier Verification Programs for Importers of Food for Humans and
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FSVP Records -Modified Requirements

21 CFR 1.507, 1.511, 1.512, 1.513

Section 1.507 – What requirements apply when I import a food that cannot be
consumed without the hazards being controlled or for which the hazards are
controlled after importation?

On January 5, 2018, FDA issued guidance stating the Agency’s policy regarding
enforcement discretion regarding certain entities and activities covered by the FSMA
regulations, including the written assurances in section 1.507 of the FSVP regulation. The
records requirements relating to these written assurances are marked with asterisks (**),
below at the beginning and end of each requirement. During the enforcement discretion
period, the Agency does not intend to enforce the provisions in section 1.507 relating to
these written assurances, indicated below with asterisks (**). The enforcement discretion
policy will be in place until FDA takes further action to address concerns relating to
application of the written assurance requirements. For additional information on the
Agency’s enforcement discretion policy, please see “Policy Regarding Certain Entities
Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce
Safety, and/or Foreign Supplier Verification Programs.”

Records: Food cannot be consumed without application of a control

 Hazard analysis
 Determination that food cannot be consumed without application of a control
Records: Customer subject to Preventive Controls regulation
 Hazard analysis
 Document accompanying food discloses that food is “not processed to control [identified
hazard]”
 **Customer’s annual written assurance, including:
> Customer established and following procedures that will significantly minimize or
prevent the identified hazard
> Effective date, printed names and signatures of authorized officials, applicable
assurance**

Records: Customer not subject to Preventive Controls regulation

 Hazard analysis
 Document accompanying food discloses that food is “not processed to control [identified
hazard]”
 **Customer’s annual written assurance, including:
> Customer is manufacturing, processing, or preparing food according to applicable
food safety regulations
> Effective date, printed names and signatures of authorized officials, applicable
assurance**

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Records: Entity in supply chain subsequent to customer controls hazard

 Hazard analysis
 Document accompanying food discloses that food is “not processed to control [identified
hazard]”
 **Customer’s annual written assurance, including:
> Customer will disclose in document accompanying food that food is “not processed
to control [identified hazard]”
> Customer will only sell food to entity that agrees, in writing, to follow procedures that
will significantly minimize or prevent identified hazard, or obtain similar written
assurance from the entity’s customer
> Effective date, printed names and signatures of authorized officials, applicable
assurance**

Records: Importer established and implemented a system to ensure customer or

subsequent entity in supply chain controls hazard
 Hazard analysis
 System established by importer
 Implementation of established system
_________________________________________________________________________

Section 1.511 - What FSVP must I have if I am importing a food subject to certain
dietary supplement current good manufacturing practice regulations?

Records: Importer who is subject to certain dietary supplement CGMPs (i.e., 21 CFR
111.70(b) or (d) and 111.73 and 111.75)
 Use of qualified individual and qualified auditor, when applicable (21 CFR 1.503)

Records: Importer whose customer who is subject to certain dietary supplement CGMPs
(i.e., 21 CFR 111.70(b) or (d) and 111.73 and 111.75)
 Annual assurance that customer is in compliance with requirements in 21 CFR 111.73
and 111.75 applicable to determining that the specifications they established are met
> Effective date, printed names, signatures of authorized officials, and a paragraph
describing the specifics related to the type of assurance
 Use of qualified individual and qualified auditor, when applicable (21 CFR 1.503)

Records: Importer for which neither they nor their customer is subject to certain dietary
supplements CGMPs (i.e., 21 CFR 111.70(b) or (d) and 111.73 and 111.75)
 Evaluation of risk posed by the food and performance of the foreign supplier (section
1.505(a)(2))

 Procedures for importing food from approved foreign suppliers

OR
 Review and assessment of procedures established by another entity for importing food
from approved foreign suppliers

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 Foreign Supplier Verification Programs for Importers of Food for Humans and
Animals (FSVP) Regulation Records Requirements

 Procedures for importing food from unapproved foreign suppliers when necessary and
appropriate, including adequate verification activities prior to importation
OR
 Review and assessment of procedures established by another entity for importing food
from unapproved foreign suppliers when necessary and appropriate, including adequate
verification activities prior to importation

 Use of procedures for importing food from approved foreign suppliers and, when
necessary and appropriate, from unapproved foreign suppliers
 Approval of foreign supplier (section 1.505(b))
 Reevaluation of supplier approval based on new information relating to factors used as
basis for approval, or at the end of any 3-year period during which a reevaluation was
not conducted (section 1.505(c)), including:
> Appropriateness of continuing to use foreign supplier
> Any subsequent actions taken based on reevaluation
 Corrective actions, investigations, and FSVP modifications based on determination that
foreign supplier is not producing food in compliance with applicable (dietary supplement)
regulations (section 1.508) (if applicable)
 Procedures for ensuring appropriate supplier verification activities conducted

 Determination of verification activities that will be conducted, including

> Frequency of conducting activity
OR
 Review and assessment of another entity’s determination of appropriate verification
activities (section 1.505(d)), including:
> Other entities determination is appropriate, including frequency
> Determination made by qualified individual
 Use of qualified individual and qualified auditor, when applicable (21 CFR 1.503)

Records: Foreign supplier verification activities (document or obtain documentation of

appropriate foreign supplier activity conducted by another entity)
 Onsite audit
> Audit procedures, audit dates, conclusions, corrective actions, conducted by
qualified auditor
> Considers applicable requirements of dietary supplements regulations (21 CFR part
111)
> Includes review and implementation of foreign supplier’s written food safety plan, if
any
OR
> Considers relevant laws and regulations of a systems recognition country
OR

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 Foreign Supplier Verification Programs for Importers of Food for Humans and
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> Results of an inspection (substituted for onsite audit)

o Conducted within 1 year of date by which onsite audit would have been required
o Determined foreign supplier’s compliance with applicable requirements in 21 CFR
part 111
o Conducted by FDA, representatives of other Federal Agencies (such as the
USDA), or representatives of State, local, tribal, or territorial agencies
OR
o Conducted by food safety authority of a systems recognition country
→ Food is within the scope of the official recognition or equivalence
determination
→ Foreign supplier is in, and under regulatory oversight of the systems
recognition country
 Sampling and testing of dietary supplement
> Number of samples tested, type of tests conducted, dates of tests, date of test
report, results, corrective actions, testing laboratory, performed by qualified individual
> Conducted before importing the dietary supplement and periodically thereafter
 Review foreign supplier’s food safety records
> Dates, general nature of records reviewed, conclusions, corrective actions,
conducted by qualified individual
> Conducted before importing the dietary supplement and periodically thereafter
 Other verification activities
> Description of activity, date activity conducted, findings or results, any corrective
actions taken, conducted by qualified individual
> Conducted before importing the dietary supplement and periodically thereafter
 Review of results of supplier verification activity performed by the importer
OR
 Review of results of supplier verification activity performed by another entity to ensure
the supplier is producing the dietary supplement consistent with part 111. (Not required
to retain documentation of supplier verification activity conducted by another entity but
must obtain the documentation and make it available to FDA upon request.)

 Documentation of any corrective actions taken, investigations, and FSVP modifications

based on determination that foreign supplier is not producing food in compliance with
applicable dietary supplement regulations
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Section 1.512 - What FSVP may I have if I am a very small importer or if I am

importing certain food from certain small foreign suppliers?

Records: Very small importer

 Meets definition of very small importer, before initially importing food and thereafter on
an annual basis by December 31 of each calendar year
 Written assurance that foreign supplier is producing food in compliance with processes
and procedures that provide applicable public health protection, before importing food
and at least every 2 years thereafter
 Corrective actions taken in response to determination that foreign supplier does not
produce food in a manner as stated in written assurance (if applicable)
 Use of qualified individual and qualified auditor, when applicable (21 CFR 1.503)

Records: Importer of food from small foreign supplier that is a qualified facility
 Written assurance before importing the food and at least every 2 years thereafter, that
foreign supplier is producing the food in compliance with applicable FDA food safety
regulations (or, when applicable, the relevant laws and regulations of a country whose
food safety system the FDA has officially recognized as comparable or determined to be
equivalent to that of the United States)
> Brief description of preventive controls supplier is implementing to control the
applicable hazard;
OR
> Statement that supplier is in compliance with State, local, county, tribal, or other
applicable non-Federal food safety law, including relevant laws and regulations of
foreign countries.

Records: Importer of food from small foreign supplier that is a farm that grows produce that
is not “covered produce”
 Written assurance before importing the food and at least every 2 years thereafter, that
the farm acknowledges that its food is subject to section 402 of the FD&C Act (or, when
applicable, that its food is subject to the relevant laws and regulations of a country
whose food safety system the FDA has officially recognized as comparable or
determined to be equivalent to that of the United States)

Records: Importer of food from small foreign supplier that is a shell egg producer with
fewer than 3,000 laying hens
 Written assurance before importing the shell eggs and at least every 2 years thereafter,
that the shell egg producer acknowledges that its food is subject to section 402 of the
FD&C Act (or, when applicable, that its food is subject to relevant laws and regulations
of a country whose food safety system the FDA has officially recognized as comparable
or determined to be equivalent to that of the United States)

Other Records: Importer of food from small foreign supplier

 Written assurance that foreign supplier meets the criteria for a small foreign supplier
before first approving the supplier for an applicable calendar year and thereafter on an
annual basis by December 31 of each calendar year, for the following calendar year

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 Foreign Supplier Verification Programs for Importers of Food for Humans and
Animals (FSVP) Regulation Records Requirements

 Corrective actions taken if importer determines that foreign supplier does not produce
the imported food consistent with a written assurance

 Initial evaluation of foreign supplier’s compliance history

> Evaluation of applicable food safety regulations and information relevant to the
compliance history of that foreign supplier
o Other factors relevant to the foreign supplier’s performance
OR
 Review and assessment of another entity’s initial evaluation of foreign supplier’s
compliance history, including:
> Evaluation performed by qualified individual

 Reevaluation of foreign supplier’s compliance history if new information or concerns are

obtained or at the end of any 3-year period, including:
> Appropriateness of continuing to use foreign supplier
> Corrective actions taken (if applicable)
OR
 Review and assessment of another entity’s reevaluation of foreign supplier’s compliance
history, including:
> Reevaluation performed by qualified individual
 Approval of foreign supplier

 Procedures for importing food only from approved foreign suppliers

OR
 Review and assessment of procedures established by another entity for importing food
only from approved foreign suppliers

 Use of procedures for importing food from approved suppliers

 Procedures for importing food from unapproved foreign suppliers when necessary and
appropriate
> Must subject food to adequate verification activities prior to importing the food
OR
 Review and assessment of procedures established by another entity for importing food
from unapproved foreign suppliers when necessary and appropriate

 Use of procedures for importing food from unapproved suppliers when necessary and
appropriate
 Use of qualified individual and qualified auditor, when applicable (21 CFR 1.503)

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 Foreign Supplier Verification Programs for Importers of Food for Humans and
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Records Requirements
 Records kept as original records, true copies (such as photocopies, pictures, scanned
copies, microfilm, microfiche, or other accurate reproductions of the original records), or
electronic records
 Records signed and dated upon initial completion and any modification
 Records legible and stored to prevent deterioration or loss
 Records available promptly to authorized FDA representative, upon request, for
inspection and copying
 English translation provided within a reasonable time, upon FDA request
 Records stored offsite retrieved and provided onsite within 24 hours of FDA request
 Records sent to Agency electronically, or through another means that delivers the
records promptly, upon written FDA request
 Records retained until at least 2 years after created or obtained, or records related to
processes and procedures retained for at least 2 years after their use was discontinued.
 Records relied on during the 3-year period preceding the applicable calendar year to
support importer status as a very small importer retained for at least 3 years
_________________________________________________________________________

Section 1.513 - What FSVP may I have if I am importing certain food from a country
with an officially recognized or equivalent food safety system?

 Documentation required before importing a food and annually thereafter:

> Foreign supplier is under the regulatory oversight of the officially recognized or
equivalent food safety system
> Food is within the scope of official recognition or equivalency determination
> Foreign supplier is in good compliance standing with comparable or equivalent food
safety authority
 Any corrective actions taken (if applicable)

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