FDA WARNING_LETTER - LA SERRANITA IMPORT AND EXPORT LLC - April 13, 2022

The FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of La Serranita Import and Export LLC in Elizabeth, NJ, from March 30 to April 13, 2022, following a previous inspection in 2020. The inspection aimed to assess compliance with section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR part 1, subpart L, which mandates importers perform risk-based activities to verify imported foods meet U.S. safety standards. The FDA found significant violations, specifically that the firm failed to develop, maintain, and follow an FSVP for imported foods, including frozen corn cobs, frozen whole yellow hot pepper, and special white cheese of Cayambe. This non-compliance violates 21 CFR 1.502(a). Although the firm provided some documents, including certificates of analysis, there was no information on how these would be used as part of an FSVP. The FDA requires a written response within fifteen working days detailing corrective actions, including documentation like a copy of the FSVP and records of its implementation. Failure to adequately address these violations may lead to refusal of admission for imported foods under section 801(a)(3) of the FD&C Act, detention without physical examination (DWPE) under Import Alert # 99-41, and prohibition of importation under section 301(zz) of the FD&C Act.