FDA WARNING_LETTER - Lempira Distribution Llc - July 16, 2021

The FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Lempira Distribution LLC from June 9, 2021, to July 16, 2021, following a previous inspection in December 2017. 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 verify imported food meets U.S. safety standards.

The inspection revealed significant violations, specifically that Lempira Distribution LLC failed to develop, maintain, and implement an FSVP for imported food products, as required by 21 CFR 1.502(a). This non-compliance was noted on Form FDA 483a.

Lempira's July 26, 2021, response, stating efforts to create food safety plans and FSVPs, was deemed inadequate due to a lack of detailed documentation or submitted FSVPs.

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.

Lempira Distribution LLC must respond in writing