FDA WARNING_LETTER - JC FINEST PRODUCE INC - March 08, 2024

On June 24, 2024, the FDA issued a Warning Letter to JC Finest Produce Inc. following inspections on March 7-8, 2024, and July 26-August 7, 2023. The inspections assessed compliance with the Foreign Supplier Verification Program (FSVP) regulation (21 CFR part 1, subpart L) and section 805 of the FD&C Act.

The primary violation identified was the failure to develop, maintain, and follow an FSVP for imported foods, including "covered produce" as defined in 21 CFR 112.3. This means the company did not demonstrate that its foreign suppliers produce food in compliance with U.S. food safety standards, specifically those under section 419 of the FD&C Act and 21 CFR part 112 (Standards for Produce Safety).

A Form FDA 483a, FSVP Observations, was issued on March 8, 2024, but no response was received. Failure to adequately address these violations may lead to refusal of admission for imported food under section 801(a)(3) of the FD&C Act, placement on Detention Without Physical Examination (DWPE) via Import Alert #99-41, and prohibition of importation under section 301(zz) of the FD&C Act.

JC Finest Produce