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          Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements Due to COVID-19Search for FDA Guidance Documents GUIDANCE DOCUMENT
	Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements Due to COVID-19
					Guidance for Industry
		
		July 2023


	Download the  Final Guidance Document 

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    PrintDocket Number:
		    FDA-2023-D-2828
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Food Safety and Applied Nutrition


**Issued March 2020
Updated June 2020; July 2023**

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 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 Agency’s 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.

Download the Full Guidance

[1] For more information on part 117, including links to guidance that discusses the requirements mentioned in this document, see FSMA Final Rule for Preventive Controls for Human Food.

[2] For more information on part 507, including links to guidance that discusses the requirements mentioned in this document, see FSMA Final Rule for Preventive Controls for Animal Food.

[3] For more information on the FSVP regulation, including links to guidance that discusses the requirements mentioned in this document, see FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals.

Related Information

FDA Updates Duration of Enforcement Discretion Policies in Two COVID-19 Era FSMA Guidances  July 13, 2023
	FDA Issues Federal Register Notice to Announce Status of COVID-19 Guidance Documents When Public Health Emergency Expires March 10, 2023
	FDA To Temporarily Conduct Remote Importer Inspections Under FSVP Due to COVID-19 April 3, 2020
	FSMA Final Rule for Preventive Controls for Human Food
	FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
	FSMA Final Rule for Preventive Controls for Animal Food
	Imports & Exports Guidance Documents & Regulatory Information
	FDA COVID-19 Information
	FDA Briefing for Foods Stakeholders on Coronavirus Disease 2019 (COVID-19)Submit Comments
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						All written comments should be identified with this document's docket number: FDA-2023-D-2828.

                                                                                  Content current as of:
      07/13/2023
         
                  
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