FDA WARNING_LETTER - Key Foods Co. dba Key Food Services - April 25, 2024

On June 27, 2024, the FDA issued a Warning Letter to Key Foods Co. dba Key Food Services following a Foreign Supplier Verification Program (FSVP) inspection from April 11-25, 2024, and a prior inspection from April 3-17, 2023. The inspection found the company was not in compliance with Section 805 of the FD&C Act and 21 CFR Part 1, Subpart L, which requires importers to perform risk-based activities to verify imported food meets U.S. food safety standards.

The significant violation identified was the failure to develop, maintain, and follow an FSVP for any imported foods, including specific unnamed products. The FDA acknowledged the company's May 6, 2024, response stating intent to take FSPCA/FSVP training and develop plans, but found it inadequate due to a lack of supporting documentation for planned or completed corrective actions.

Failure to address these violations may result in refusal of admission for imported food under Section 801(a)(3) of the FD&C Act, potential detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation under Section 301(zz). Key Foods Co. must respond in writing within fifteen working days, detailing corrective actions with supporting documentation, or explain delays and provide a timeline for