FDA WARNING_LETTER - bob gosman co inc - March 22, 2013

An FDA inspection of Bob Gosman Co., Inc. d/b/a Gosman's Fish Market, Inc. in Montauk, NY, conducted on March 20-22, 2013, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 C.F.R. Part 123). Consequently, the firm's ready-to-eat raw tuna and fluke products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The primary deficiencies include the failure to conduct a hazard analysis and implement written HACCP plans for ready-to-eat raw tuna and fluke, as required by 21 CFR 123.6(a). The firm's provided HACCP plans were merely drafts and not finalized or implemented to control hazards like pathogen growth, scombrotoxin formation, and parasites. Additionally, the firm failed to implement an affirmative step to ensure imported raw tuna from (b)(4) was processed in accordance with 21 CFR 123.12(a)(2)(ii), with the provided health certificate being insufficient. The FDA warns that failure to promptly correct these violations could lead to further action, including refusal of admission for imported products, detention without physical examination, product seizure, injunction, and assessment of reinspection fees. The firm must respond in writing within fifteen working days, detailing specific corrective actions and providing supporting documentation, such as finalized HACCP and importer verification records. The letter emphasizes the firm's responsibility for overall compliance with the Act and seafood HACCP regulations.