FDA WARNING_LETTER - Facema, LLC. - August 03, 2022

The FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Facema, LLC. from May 20, 2022, through August 3, 2022, following previous inspections on September 25-26, 2019. The purpose was 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 ensure imported food meets U.S. safety standards.

The inspection revealed significant violations: Facema, LLC. failed to develop, maintain, and follow an FSVP for any imported foods, including a specific unnamed food, as required by 21 CFR 1.502(a). This non-compliance also violates section 805 of the FD&C Act. An FDA Form 483a FSVP Observations was issued on August 3, 2022, but no response has been received.

Failure to address 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.

Facema, LLC. must respond in writing within fifteen working