F1 Foods Inc. D/B/A Flavor First Foods Inc. – FDA Warning Letter, Aug 15, 2023

The FDA conducted an inspection of a ready-to-eat (RTE) prepared foods facility, including seafood and acidified food products, located at 255 Walnut Street, West Bridgewater, MA, from July 18 to August 15, 2023. The inspection revealed serious violations of Emergency Permit Control (21 CFR Part 108), Acidified Foods (21 CFR Part 114), Seafood Hazard Analysis and Critical Control Point (HACCP) (21 CFR Part 123), and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (CGMP & PC rule) (21 CFR Part 117) regulations. These violations render the RTE products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: * **Acidified Foods:** Failure to file scheduled processes for "(b)(4) Marinara Sauce" with the FDA and lack of an FDA-approved trained supervisor for pH controls and critical factors in acidification. * **Seafood HACCP:** Failure to implement monitoring procedures at critical control points for refrigerated, RTE, heat-treated clam chowder in reduced oxygen packaging, specifically regarding continuous temperature monitoring during hot filling and cooking, and monitoring of residual chlorine in cooling water. * **Current Good Manufacturing Practice:** Failure to ensure proper handwashing, maintain clean