FDA WARNING_LETTER - Stagnaro Bros Seafood Inc - June 27, 2012

The FDA inspected Stagnaro Bros. Seafood, Inc. from June 18-27, 2012, identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123. Consequently, the firm's refrigerated vacuum packaged ready-to-eat smoked fish, refrigerated histamine forming fish (tuna), refrigerated, canned, cooked ready-to-eat crabmeat, and refrigerated, canned raw scallops were deemed adulterated. Key deficiencies included the failure to conduct a proper hazard analysis and list all reasonably likely food safety hazards, specifically allergens, in HACCP plans (21 CFR 123.6(a) and (c)(1)). The firm also lacked adequate critical limits in HACCP plans to control pathogen growth and toxin formation, including Clostridium botulinum toxin, for various products (21 CFR 123.6(c)(3)). Furthermore, monitoring procedures and frequencies for critical control points were insufficient to control histamine formation and pathogen growth (21 CFR 123.6(c)(4)). Finally, the corrective action plans in all three HACCP plans were deemed inappropriate, failing to prevent adulterated product from reaching consumers or address root causes (21 CFR 123.7(b)). The FDA requires a written response within fifteen working days detailing specific corrective actions, including revised HACCP plans and supporting documentation. Failure to promptly correct these violations may result in further regulatory action, such as product seizure or an injunction against the firm's operations.