Trafon Group, Inc. – FDA Warning Letter, Feb 6, 2012

The FDA inspected Trafon Group, Inc. dba Star Meat's seafood processing and importer facility from January 26 to February 6, 2012, identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123. Consequently, the firm's frozen seafood products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key violations include the firm's failure as an importer to implement affirmative steps and maintain product specifications to ensure imported fish and fishery products comply with HACCP and are not injurious to health, as required by 21 CFR 123.12(a)(2)(ii) and 123.12(a)(2)(i). Additionally, the HACCP plan for "frozen raw fish" products lacks a critical control point for controlling metal fragments during the "slicing, cutting, trimming" process, violating 21 CFR 123.6(a) and (c)(2). The firm also failed to maintain sanitation monitoring records for preventing cross-contamination, protecting food, and excluding pests during cutting and re-packaging operations, contrary to 21 CFR 123.11(c). The firm was previously notified of HACCP non-compliance in June 2011. FDA requires a written response within fifteen working days detailing specific corrections, including updated HACCP plans, sanitation monitoring, and importer verification records. Failure to comply may result in refusal of admission, detention, seizure, injunction, and re-inspection fees.