FDA WARNING_LETTER - Pepe’s Foods Inc. - July 21, 2022

On October 19, 2022, the FDA issued a Warning Letter to Pepe’s Foods INC following Foreign Supplier Verification Program (FSVP) inspections conducted on July 14-21, 2022, and July 27, 2021. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L.

The FDA found that Pepe’s Foods INC is not in compliance with FSVP requirements for imported foods. The significant violation identified is the failure to develop, maintain, and follow an FSVP as required by 21 CFR 1.502(a) for any imported foods. A Form FDA 483a, FSVP Observations, was issued on July 21, 2022, but no response has been received.

Failure to address these violations may lead to further FDA action, including refusal of admission of imported food under section 801(a)(3) of the FD&C Act, and potential 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.

Pepe’s Foods INC must respond in writing within fifteen working days, detailing corrective actions, providing supporting documentation (e.g.,