FDA WARNING_LETTER - Bacocas Enterprises Inc. - April 08, 2022

On April 8, 2022, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Bacocas Enterprises, Inc., following a previous inspection on June 16, 2020. The inspection revealed significant violations of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the implementing FSVP regulation (21 CFR part 1, subpart L).

Specifically, Bacocas Enterprises, Inc. failed to develop, maintain, and follow an FSVP for any imported food, including products from a supplier in (b)(4), violating 21 CFR 1.502(a). The FDA issued a Form FDA 483a, FSVP Observations, on April 8, 2022, to which no response has been received.

The FDA noted that imported watermelons are "covered produce" (21 CFR 112.3), requiring the FSVP to demonstrate supplier compliance with produce safety standards (21 CFR part 112). Failure to address these violations may result in refusal of admission for imported food under section 801(a)(3) of the FD&C Act, detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation under section 301(zz) of the FD&C Act.

Bacocas Enterprises, Inc