FDA WARNING_LETTER - Supreme Fruit Produce, Inc. - March 30, 2022

On June 1, 2022, the FDA issued a Warning Letter to Supreme Fruit Produce, Inc. following Foreign Supplier Verification Program (FSVP) inspections conducted from March 18-30, 2022, and previously from October 13-21, 2020. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L, concerning imported human and/or animal food.

The FDA found the firm non-compliant with FSVP requirements for imported foods, including fresh Chayote, fresh Serrano peppers, and fresh coconuts from (b)(4). The primary violation cited was the failure to develop, maintain, and follow an FSVP as required by 21 CFR part 1.502(a) for any imported foods.

The firm's April 8, 2022, response, which indicated plans to implement an FSVP by "end of July 2022," was deemed inadequate due to a lack of detailed documentation or evidence of implementation. The FDA emphasized that the FSVP must demonstrate compliance with produce safety standards (21 CFR part 112).

Failure to adequately address these violations may lead to refusal of admission for imported food products under section 801(a)(3) of the FD&C Act, potential detention without physical examination (DW