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FDA Withdraws Temporary COVID FSMA Guidances Related to Onsite Audits

FDA Guidance Update

FDA Ends COVID-Era Flexibility for FSMA Onsite Audit Requirements

The U.S. Food and Drug Administration has announced it is withdrawing two temporary guidances issued during the COVID-19 public health emergency related to onsite audit and verification requirements under the Food Safety Modernization Act (FSMA).

These guidances previously allowed flexibility when travel restrictions made onsite supplier audits impracticable.

The withdrawal will take effect June 16, 2026, following a 90-day transition period.

What Is Changing

During the COVID-19 pandemic, FDA exercised enforcement discretion to allow alternative supplier verification activities when onsite audits could not be conducted.

One of the primary guidances, Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements Due to COVID-19, stated FDA’s intent not to enforce onsite audit requirements under certain circumstances when other verification methods were used instead.

A related guidance, Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements Due to COVID-19, addressed flexibility for onsite observation requirements and certification durations under the Accredited Third-Party Certification Program.

With the withdrawal of these guidances:

  • FDA will no longer permit routine substitution of onsite audits with remote or alternative verification methods due to COVID-related constraints
  • Standard FSMA requirements for onsite audits and observations will resume

The following comparison highlights how FDA expectations are shifting as these temporary policies are withdrawn:

 

Area During COVID Guidance After Withdrawal
(Effective June 16, 2026)
Onsite Supplier Audits FDA did not intend to enforce onsite audit requirements when travel was not feasible Onsite audits are expected where required under FSMA
Alternative Verification Methods Remote audits and other verification activities were permitted in place of onsite audits Alternative methods alone are no longer sufficient when onsite audits are required
FSVP Requirements Importers could rely on alternative verification when onsite audits were impracticable Importers must ensure onsite audits are conducted when required based on risk
Accredited Third-Party Certification Flexibility for onsite observation and certificate duration Standard certification and observation requirements resume
Regulatory Enforcement Enforcement discretion applied due to pandemic conditions Standard enforcement expectations apply

Affected Regulations

The withdrawal impacts requirements under:

  • 21 CFR Part 117 – Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
  • 21 CFR Part 507 – Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
  • 21 CFR Part 1, Subpart L – Foreign Supplier Verification Programs (FSVP)
  • Accredited Third-Party Certification Program requirements

Background

FDA originally issued these temporary guidances during the COVID-19 public health emergency to address travel restrictions that limited the ability to conduct onsite audits and inspections.

Although the public health emergency ended in May 2023, FDA extended the policies to accommodate lingering travel and operational disruptions.

FDA now states that such constraints are no longer widespread, and the temporary policies are no longer necessary.

What This Means for Industry

Food manufacturers, importers, and supply chain partners should prepare to return to full compliance with onsite audit requirements.

Companies may wish to:

  • Review supplier verification programs and audit schedules
  • Resume or schedule required onsite audits
  • Confirm third-party certification practices align with current requirements
  • Evaluate any reliance on remote verification methods implemented during COVID

EAS Perspective

The withdrawal marks a transition back to standard FSMA enforcement expectations. Companies that adjusted supplier verification programs during the pandemic should ensure those programs are realigned with regulatory requirements ahead of the June 2026 effective date.

EAS will continue monitoring FDA communications related to FSMA implementation and provide updates as needed.

Source: FDA Human Foods Program Constituent Update

Date: March 17, 2026

Posted in FDA and USDA Regulatory Update, Foods.