Temporary Policy Regarding 
Preventive Controls and FSVP Food 
Supplier Verification Onsite Audit 
Requirements Due to COVID-19 
Guidance for Industry 
Additional copies are available from: 
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Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
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College Park, MD  20740 
(Tel) 240-402-2166 
or 
Center for Veterinary Medicine HFV-200 
Food and Drug Administration 
7519 Standish Place 
Rockville, MD 20855 
(Tel) 240-402-6246 
http://www.fda.gov/FoodGuidances 
You may submit electronic or written comments regarding this guidance at any time.  Submit 
electronic comments to https://www.regulations.gov.  Submit written comments on the 
guidance to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.  All comments should be identified with the 
Docket No. FDA-2023-D-2828.   
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
Center for Veterinary Medicine 
Document issued July 2023 
This document supersedes Temporary Policy Regarding Preventive Controls and FSVP 
Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public 
Health Emergency issued June 15, 2020.  Contains Nonbinding Recommendations 
Table of Contents 
 
 
I. Introduction ................................................................................................................................. 1 
II. Background ................................................................................................................................ 2 
III. Discussion ................................................................................................................................. 4 
 
 
 
  Temporary Policy Regarding 
Preventive Controls and FSVP Food 
Supplier Verification Onsite Audit 
Requirements Due to COVID-19:  
Guidance for Industry 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA, the Agency, or 
we) on this topic.  It does not establish any rights for any person and is not binding on FDA or the public.  
You can use an alternative approach if it satisfies the requirements of the applicable statutes and 
regulations.  To discuss an alternative approach, contact the FDA staff responsible for this guidance as 
listed on the title page. 
 
I. Introduction  
 
The purpose of this guidance is to state the current intent of the Food and Drug Administration 
(FDA, we, or the Agency), in certain circumstances related to the impact of the coronavirus 
outbreak (COVID-19), not to enforce requirements in three foods regulations to conduct onsite 
audits of food suppliers if other supplier verification methods are used instead.   
 
The three regulations are Current Good Manufacturing Practice, Hazard Analysis, and Risk-
Based Preventive Controls for Human Food (21 CFR part 117) (part 117) 1, Current Good 
Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for 
Animals (21 CFR part 507) (part 507) 2, and Foreign Supplier Verification Programs for 
Importers of Food for Humans and Animals (21 CFR part 1 subpart L) (FSVP regulation) 3.   
 
This guidance (originally titled Temporary Policy Regarding Preventive Controls and FSVP 
Food Supplier Verification Onsite Requirements During the COVID-19 Public Health 
Emergency) was initially implemented without prior public comment on March 17, 2020, 
because FDA had determined that prior public participation was not feasible or appropriate (21 
CFR 10.115(g)(2)) given the exigent circumstances related to the COVID-19 public health 
emergency.  FDA revised the guidance on June 4, 2020, to clarify how the policies apply to 
 
1 For more information on part 117, including links to guidance that discusses the requirements mentioned in this 
document, see https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-preventive-controls-
human-food. 
2 For more information on part 507, including links to guidance that discusses the requirements mentioned in this 
document, see https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-preventive-controls-
animal-food. 
3 For more information on the FSVP regulation, including links to guidance that discusses the requirements 
mentioned in this document, see https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-
foreign-supplier-verification-programs-fsvp-importers-food-humans-and-animals. 
1 
  Contains Nonbinding Recommendations 
importers of dietary supplements.  For the reasons discussed in Section II.B., and to clarify that 
the policies continue to reflect our current thinking, FDA is now reissuing this guidance in 
accordance with 21 CFR 10.115(c) and 10.115(g)(4).  The policies are unchanged from the June 
2020 guidance.  
 
In general, FDA's guidance documents do not establish legally enforceable responsibilities.  
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
the word should in Agency guidances means that something is suggested or recommended, but 
not required.  
 
II. Background  
 
A. Onsite Audits under Part 117, Part 507, and the FSVP Regulation 
 
This guidance concerns three regulations that we have established in Title 21 of the Code of 
Federal Regulations (21 CFR) as part of our implementation of the FDA Food Safety 
Modernization Act (FSMA; Pub. L. 111353)4: part 117, part 507, and the FSVP regulation.     
 
Subparts A, B, and F of part 117 include current good manufacturing practice (CGMP) 
requirements for manufacturing, packing, or holding human food.  Subparts A, C, D, E, F, and G 
of part 117 include requirements for domestic and foreign facilities that are required to register 
under section 415 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 
350d) to conduct a hazard analysis and implement risk-based preventive controls for human food 
(the human food preventive controls requirements).  Subpart G of part 117 establishes 
requirements for a supply-chain program for those raw materials and other ingredients for which 
a receiving facility has identified a hazard requiring a supply-chain-applied control. 
 
For domestic and foreign facilities that are required to register, subparts A, B, and F of part 507 
include CGMP requirements for animal food, and subparts A, C, D, E, and F of part 507 include 
requirements to conduct a hazard analysis and implement risk-based preventive controls for 
animal food (the animal food preventive controls requirements).  Subpart E of part 507 
establishes requirements for a supply-chain program for those raw materials and other 
ingredients for which a receiving facility has identified a hazard requiring a supply-chain-applied 
control.   
 
Under the FSVP regulation, FSVP importers of human and animal food are generally required to 
develop, maintain, and follow a foreign supplier verification program that provides adequate 
assurances that imported food meets applicable U.S. food safety standards.  The applicable U.S. 
food safety standards vary depending on the product.   
 
An FSVP importer that is a receiving facility subject to section 418 of the FD&C Act is deemed 
to be in compliance with the requirements of the FSVP regulation, except the importer 
identification requirements in 21 CFR 1.509, if the FSVP importer has established and 
 
4 For more information on the Agencys implementation of FSMA, see http://www.fda.gov/fsma. 
2 
  Contains Nonbinding Recommendations 
implemented a risk-based supply-chain program in compliance with 21 CFR part 117, subpart G 
or part 507, subpart E (21 CFR 1.502(c)(3)). 
 
Part 117 defines a receiving facility as a facility that is subject to the human food preventive 
controls requirements and that manufactures/processes a raw material or other ingredient that it 
receives from a supplier.  Part 117 defines a supplier as the establishment that 
manufactures/processes the food, raises the animal, or grows the food that is provided to a 
receiving facility without further manufacturing/processing by another establishment, except for 
further manufacturing/processing that consists solely of the addition of labeling or similar 
activity of a de minimis nature.  Part 117 defines a supply-chain-applied control as a preventive 
control for a hazard in a raw material or other ingredient when the hazard in the raw material or 
other ingredient is controlled before its receipt.  For animal food, part 507, subpart A, contains 
similar definitions for receiving facility, supplier, and supply-chain-applied control (21 
CFR 507.3).  The FSVP regulation applies to importers, some of which may be receiving 
facilities; it also contains similar definitions (21 CFR 1.500). 
 
Among other things, subpart G in part 117 requires the receiving facility to establish and 
implement a written supply chain-program (21 CFR 117.405(a)-(b)) and approve suppliers for 
those raw materials and other ingredients for which the receiving facility has identified a hazard 
requiring a supply-chain-applied control (21 CFR 117.415(a)(1)). The receiving facility (or a 
designee) also must determine and conduct appropriate supplier verification activities (21 CFR 
117.425, 21 CFR 117.415(a)(3)(iii)).  With some exceptions, one or more supplier verification 
activities (e.g., onsite audit, sampling and testing, review of food safety records) must be 
conducted for each supplier before using the raw material or other ingredient from that supplier 
and periodically thereafter (21 CFR 117.430(a)).  
 
Generally, when a hazard in a raw material or other ingredient will be controlled by the supplier 
and is one for which there is a reasonable probability that exposure to the hazard will result in 
serious adverse health consequences or death, the appropriate supplier verification activity is an 
onsite audit of the supplier, and it must be conducted before using the food and at least annually 
thereafter (21 CFR 117.430(b)(1)).    
 
Animal food facilities are subject to comparable supply-chain program requirements in subpart E 
of part 507.   
 
Similarly, the FSVP regulation requires importers to conduct a hazard analysis to determine 
whether there are any hazards that require a control (21 CFR 1.504) and, based on the hazard 
determine the appropriate type of verification activity as well as the frequency of conducting the 
activity.  The foreign supplier verification activities must provide assurance that the hazards 
requiring a control in the imported food have been significantly minimized or prevented (21 CFR 
1.506(c)).  Importers must establish and follow written procedures to ensure they import food 
only from suppliers they have approved (21 CFR 1.506(a)(1)).  Appropriate supplier verification 
activities may include onsite audits, sampling and testing of a food, and review of the foreign 
suppliers relevant food safety records (21 CFR 1.506(d)(1)(ii)). When a hazard in a food is 
controlled by the foreign supplier and is one for which there is a reasonable probability that 
exposure to the hazard will cause serious adverse health consequences or death to humans or 
3 
  Contains Nonbinding Recommendations 
animals, the default verification activity is to conduct an annual onsite audit before initially 
importing the food from the supplier and at least annually thereafter (21 CFR 1.506(d)(2)). In 
addition, audits may be a verification activity selected by importers of certain dietary 
supplements, who must determine and document which verification activity or activities, as well 
as the frequency with which the activity or activities must be conducted, are needed to provide 
adequate assurances that the foreign supplier is producing the food in accordance with processes 
and procedures that provide the same level of public health protection as those required under 21 
CFR part 111 (21 CFR 1.511(c)(4)(i)-(ii)).   
B. Coronavirus
Since December 2019, governments across the globe have instituted various responses to 
outbreaks of the respiratory disease COVID-19 caused by the virus SARS-CoV-2.  Some of 
these have included instituting travel restrictions and advisories to try to curb the spread of  
COVID-19 domestically and internationally.  Since the first COVID-19 cases were reported, it 
has become clear that SARS-CoV-2 is constantly evolving, with the public health impact and 
consequent travel restrictions and advisories changing in response.  Due to the unpredictable 
nature of the SARS-CoV-2 virus and the ongoing international impact of COVID-19, FDA 
expects that, from time to time, travel advisories and restrictions may impact the ability of 
receiving facilities and FSVP importers to conduct or obtain onsite audits of their suppliers. FDA 
is issuing this revised guidance to address these circumstances. 
III. Discussion
FDA does not intend to enforce the requirement for an onsite audit in part 117, part 507, and the 
FSVP regulation in the following circumstances: 
(1) A receiving facility or FSVP importer has determined that an onsite audit is the
appropriate verification activity for an approved supplier,5 as reflected by its written food
safety plan or foreign supplier verification program;
(2) The supplier that is due for an onsite audit is in a region or country covered by a
government travel restriction or travel advisory related to COVID-19;
(3) In light of a government travel restriction or travel advisory, it is temporarily
impracticable for the receiving facility or FSVP importer to conduct or obtain the onsite
audit of the supplier (e.g., a receiving facility or FSVP importer is unable to obtain the
services of a qualified auditor in the impacted country or region or travel to the foreign
supplier to conduct the onsite audit); and
(4) The receiving facility or FSVP importer temporarily selects an alternative verification
activity or activities, such as sampling and testing food or reviewing relevant food safety
5 This policy does not apply to unapproved suppliers, because Parts 117 and 507 and the FSVP regulation provide 
for the temporary use of unapproved suppliers whose raw materials or other ingredients are subjected to adequate 
verification activities before acceptance for use or importation.  (See 21 CFR 117.420(b)(2); 21 CFR 507.120(b)
(2); 21 CFR 1.506(a)(1)).  
4  Contains Nonbinding Recommendations 
records, and modifies6 its food safety plan or foreign supplier verification program to 
incorporate the alternative activity(ies).  The alternative verification activity(ies) is 
designed, in consideration of the temporary unavailability of supplier onsite audits, to 
provide sufficient assurance that the hazard requiring a supply-chain-applied control (or, 
for FSVP, the hazard that is being controlled by the foreign supplier) has been 
significantly minimized or prevented during the period of onsite audit delay.7   
 
Receiving facilities and FSVP importers should resume onsite audits within a reasonable period 
of time after it becomes practicable to do so, and should update their food safety plans and 
foreign supplier verification programs accordingly.   
 
FDA intends to provide timely notice about the withdrawal of this policy. 
 
6 Note that part 117 requires a food safety plan to be signed and dated upon any modification (21 CFR 117.310(b)); 
part 507 and the FSVP regulation contain similar provisions (21 CFR 507.206 and 21 CFR 1.510(a)(2), 
respectively).   
7 For importers of dietary supplements, the alternative verification activity(ies) should be designed, in consideration 
of the temporary unavailability of supplier onsite audits, to provide sufficient assurance that the foreign supplier is 
producing the dietary supplement in accordance with processes and procedures that provide the same level of public 
health protection as those required under 21 CFR part 111 during the period of onsite audit delay. 
5