FDA WARNING_LETTER - Gourmet & More - June 01, 2020

On July 31, 2020, the FDA issued a Warning Letter to Gourmet and More, Inc. following remote Foreign Supplier Verification Program (FSVP) inspections on May 28 and June 1, 2020, and a previous inspection on September 12, 2018. The inspections assessed compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L.

The FDA found that Gourmet and More, Inc. was not in compliance with FSVP requirements for imported Brie Fermier Cheese and Brillat-Savarin Affine cheese. Specifically, the company failed to develop, maintain, and follow an FSVP for any imported foods, including these cheeses, violating 21 CFR 1.502(a). Although the company submitted documents, they were not translated into English, preventing evaluation.

The letter emphasizes the company's responsibility to comply with FSVP regulations. Failure to promptly correct these violations may result in refusal of admission for imported food products under section 801(a)(3) of the FD&C Act, potentially leading to detention without physical examination (DWPE) under Import Alert #99-41. Importing food without a compliant FSVP is also prohibited under section 301(zz) of the FD&C Act.

Gourmet and More, Inc. must respond in writing within fifteen working days,