Pagano's Inc. – FDA Warning Letter, Oct 10, 2014

An FDA inspection of Pagano's Inc. seafood processing facility in Norwalk, CT, conducted on October 7, 8, and 10, 2014, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). Consequently, the firm's fish and fishery products, including various ready-to-eat smoked salmon, caviar, seafood salads, pasteurized crabmeat, and herring products, are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key violations include the failure to establish adequate critical limits in HACCP plans for controlling Clostridium botulinum and pathogenic bacteria growth (21 CFR 123.6(c)(3)), improper grouping of products in HACCP plans (21 CFR 123.6(b)(2)), and a failure to implement the required record-keeping system for monitoring critical control points (21 CFR 123.6(b) and (c)(7)), a repeat observation. Additionally, the firm failed to take appropriate corrective actions when critical limit deviations occurred, specifically for refrigerated storage temperatures (21 CFR 123.7(a)), and its corrective action plan for Clostridium botulinum growth was deemed inappropriate (21 CFR 123.7(b)). The firm's October 22, 2014, response to the FDA-483 was found inadequate. Pagano's Inc. must respond within fifteen working days, outlining specific corrections with supporting documentation, or face potential further actions such as product seizure, injunction, and re-inspection fees.