FDA WARNING_LETTER - Bella Mia Foods, Inc. - February 09, 2023

The FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Bella Mia Foods, Inc. from February 1-9, 2023, following previous inspections in 2017, 2020, and 2022. 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. The FDA found the firm not in compliance with FSVP requirements, specifically citing a failure to develop, maintain, and follow an FSVP for any imported foods, as mandated by section 805 of the FD&C Act and 21 CFR section 1.502(a). The firm's responses dated February 9 and February 16, 2023, were deemed inadequate as they lacked specific procedures, information about foreign suppliers, or supporting documentation for planned corrective actions. The FDA requires a written response within fifteen working days detailing specific corrective actions, including documentation of FSVP development and implementation. Failure to adequately address these violations may result in refusal of admission of imported food, detention without physical examination (DWPE) under Import Alert # 99-41, and prohibition of importation under section 301(zz) of the FD&C Act.