- FDA appears to have stepped up its enforcement of Foreign Supplier Verification (FSVP) regulations in the past several weeks, issuing four warning letters to companies in the past month for failing to have appropriate FSVP documentation in place. FDA had issued only 10 warning letters related to FSVP compliance in the previous eight months.
- FSVP regulations require importers to have written documentation verifying that each of its foreign suppliers is producing food in accordance with U.S. food safety standards. As previously reported on this blog, FDA announced on April 3, 2020 that it is temporarily conducting remote inspections under the FSVP. As is apparent from the recent warning letters, this announcement should not be regarded as an indication that FDA is slowing its enforcement of FSVP requirements.
- Each of the firms that received FSVP-related warning letters had been inspected by FDA previously and found to not have FSVPs in place. Each firm was issued a Form 483a with FSVP Observations; FDA issued the warning letters only after finding continuing FSVP violations on reinspection.
- Keller and Heckman attorneys are available to assist interested parties in preparing the necessary documentation for and navigating compliance under the FSVP rule. For assistance, please email: fooddrug@khlaw.com.