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FDA Issues Temporary COVID-19 Policy for Receiving Facilities and Importers

 

The U.S. Food and Drug Administration (FDA) has decided to temporarily not enforce supplier verification onsite audit requirements for receiving facilities and importers under the FDA Food Safety Modernization Act (FSMA) in response to the global pandemic of COVID-19. The FDA will not be enforcing the onsite audit requirements if other supplier verification methods are used instead.

 

 

 

 

 

 

More specifically, FDA will not enforce the requirement for an onsite audit 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, as reflected by its written food safety plan or FSVP;
  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. If it is temporarily impracticable for the receiving facility or FSVP importer to conduct or obtain the onsite audit of the supplier; 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 records, and modifies its food safety plan or FSVP to incorporate the alternative activity or activities.

Receiving facilities and FSVP importers are being asked to resume onsite audits within a reasonable period of time after it becomes practicable to do so and should be updating their food safety plans and foreign supplier verification programs accordingly.

 

To view the full version of the March 17 FDA press release, click here.