Early this year, FDA began increasing FSVP inspections and issuing 483s and Warning Letters (,,as we discussed ,,in a newsletter). Then the pandemic hit, and FDA issued a statement that it would temporarily not enforce FSMA requirements for onsite FSVP audits of food suppliers if other supplier verification methods are used instead and that it would ,,temporarily conduct its importer inspections remotely, requesting that records be submitted electronically. Just last week, ,,FDA updated its policy on guidance on FSVP audits, continuing the temporary policy “exigent circumstances related to an ongoing public health threat.”
That did not mean, however, that food facilities were off the hook for verifying their foreign suppliers during COVID-19 – or responding to 483s issued before onsite inspections were discontinued. In fact, since the beginning of April, FDA has issued ,,12 FSVP warning letters (search FSVP), primarily stating it had not received a response to an issued Form FDA 483a which had found the facility, not in compliance with FSVP requirements.
Specifically, the letters tend to state: “You did not develop, maintain, and follow an FSVP as required by the FSVP rule (21 CFR 1.502(a))… Specifically your firm did not develop an FSVP for the products that you import, including [product(s)/ingredient(s)].” FDA then states that if prompt action is not taken to correct the violations, it may take further action, including refuse admission of the food products or placing the foods on detention without physical examination (DWPE).
The warning letters being issued bring up a number of issues:
For more information, assistance, or operational assessment in any of these areas, give TAG a call to discuss your situation and needs with our food safety and public health experts.
About The Acheson Group (TAG)
Led by former FDA Associate Commissioner for Foods ,Dr. David Acheson, TAG is a food safety and public health consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With the advent of the COVID-19 pandemic, TAG’s public health and infectious disease expertise has been brought to the forefront to assist food businesses weather the increased challenges of employee protection, food safety, and business continuity. With in-depth industry knowledge combined with real-world experience and advanced virtual technologies, TAG’s team of experts helps companies assess their unique situation, address gaps, and deploy best practices to more effectively mitigate risks, improve operational efficiencies, and protect their brand. ,www.AchesonGroup.com