FDA WARNING_LETTER - C. Liberatore LLC - May 05, 2022

On April 28-May 5, 2022, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of C. Liberatore LLC, following a previous inspection from April 7-29, 2021. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L, which mandate importers perform risk-based activities to verify imported food meets U.S. food safety standards.

The inspection revealed significant violations: C. Liberatore LLC failed to develop, maintain, and follow an FSVP for any imported foods, including "covered produce" as defined in 21 CFR 112.3. This violates 21 CFR 1.502(a) and section 805 of the FD&C Act. The company did not respond to the Form FDA 483a issued on May 5, 2022.

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, and potential detention without physical examination (DWPE) under Import Alert #99-41. Importing food without a compliant FSVP is also prohibited under section 301(zz) of the FD&C Act.

C. Liberatore LLC must respond in