FDA WARNING_LETTER - Frischs Commissary - January 08, 2010

The FDA inspected Frisch's Restaurant, Inc.'s seafood processing facility in Cincinnati, OH, in September 2009, with a follow-up in January 2010. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123. Consequently, the firm's tuna salad was deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, having been prepared, packed, or held under insanitary conditions. The primary violation identified was the firm's failure to conduct a comprehensive hazard analysis and implement a written HACCP plan for its tuna salad, as mandated by 21 CFR 123.6(a) and 123.6(c)(1). Specifically, the existing HACCP plan did not address the chemical food safety hazard of histamine, which is reasonably likely to occur with temperature abuse, nor did it account for physical food safety hazards like metal contamination from mixing machines used during processing. Frisch's is required to respond in writing within fifteen working days, detailing specific corrective actions, including supporting documentation such as updated HACCP and verification records. Failure to promptly correct these violations could result in further regulatory action, including product seizure or an injunction preventing the firm from operating. The letter emphasizes the firm's responsibility to ensure compliance with the Act, seafood HACCP, and Current Good Manufacturing Practice regulations.