FDA WARNING_LETTER - BC Food LA, LLC, DBA B & C Food Co. - February 23, 2023

The FDA conducted a Foreign Supplier Verification Programs (FSVP) inspection of BC Food LA, LLC, DBA B & C Food Co., from February 13-23, 2023, following previous inspections in 2019 and 2022. The inspection aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR part 1 subpart L, which mandate risk-based activities for importers to verify foreign food safety standards.

The inspection revealed significant violations: BC Food LA, LLC did not develop, maintain, and follow an FSVP as required by 21 CFR 1.502(a) for imported foods, including those specified in a list provided during the inspection. This non-compliance violates Section 805 of the FD&C Act. The FDA issued a Form FDA 483a FSVP Observations on February 23, 2023, to which no response has been received.

Failure to correct these violations may lead to further FDA action, including refusal of admission for imported food under Section 801(a)(3) of the FD&C Act, potential detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation under Section 301(zz) of the FD&C Act. BC Food LA, LLC must respond in writing within fifteen working days, detailing