Compass Logistics, LLC. – FDA Warning Letter, Aug 25, 2022

On January 4, 2023, the FDA issued a Warning Letter to Compass Logistics, LLC following a Foreign Supplier Verification Program (FSVP) inspection conducted from August 12-25, 2022, with a previous inspection on October 13, 2020. The inspection found the company was not in compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L, for most imported foods, excluding hot sauce from one specific supplier.

The primary violation cited was the failure to develop, maintain, and follow an FSVP as required by 21 CFR 1.502(a). Specifically, the company did not have an FSVP for imported fresh produce, which is "covered produce" under 21 CFR 112.3, failing to demonstrate that suppliers meet U.S. food safety standards, including those under 21 CFR part 112.

The FDA acknowledged the company's September 13, 2022, response stating a consultant was hired for FSVP compliance by December 31, 2022, and a review of small foreign suppliers would occur. However, the response was deemed inadequate due to a lack of supporting documentation or evidence of implemented corrective actions.

Failure to adequately address these violations may result in refusal of admission for imported food under section 801