FDA WARNING_LETTER - Eurobread Inc. dba First Harvest - February 07, 2025

The FDA issued a Warning Letter to Eurobread Inc., operating as First Harvest, located in Boca Raton, FL, following an inspection from February 2 to February 7, 2025. This inspection assessed compliance with the Foreign Supplier Verification Program (FSVP) under section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR part 1 subpart L. The inspection revealed significant non-compliance with FSVP requirements, particularly concerning imported Mini Patisseries linked to a Salmonella Enteritidis outbreak and subsequent Class 1 recall.

Key violations included failure to evaluate foreign suppliers" performance and the risk posed by imported foods, as mandated by 21 CFR 1.505(a) and (b). Eurobread Inc. did not adequately document the evaluation of their foreign suppliers or the review of related records. Additionally, the company did not perform or document necessary foreign supplier verification activities before importing foods, as required by 21 CFR 1.506(d) and (e).

The FDA placed the Mini Patisseries from the implicated foreign supplier on Import Alert #99-19 due to Salmonella presence and all ready-to-eat foods from the supplier on Import Alert #99-43 for unsanitary conditions. Eurobread Inc. responded by stating plans to retain a Qualified Individual to implement FSVP procedures and indicated they would cease importing from the implicated supplier, which is reportedly going out of business.

The FDA requires Eurobread Inc. to document evaluations of foreign suppliers, ensure compliance with preventive controls under 21 CFR part 117, and conduct appropriate verification activities to meet FSVP requirements.