FDA WARNING_LETTER - Fisherman's Market Ltd. - June 29, 2012

On June 28-29, 2012, the FDA inspected Fisherman's Market Ltd. in Halifax, Nova Scotia, identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). The firm's products, including mackerel, mahi mahi, marlin, herring, shad, tuna, and vacuum-packaged frozen cooked lobster, crab, and shrimp, were deemed adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: 1. **Inadequate Hazard Analysis (21 CFR 123.6(a) and (c)(1)):** HACCP plans failed to identify undeclared allergens for all products and *Clostridium botulinum* growth and toxin formation for vacuum-packaged frozen cooked lobster, crab, and shrimp. 2. **Missing Critical Control Points (21 CFR 123.6(a) and (c)(2)):** The "Mackerel, Mahi Mahi, Marlin, Herring, Shad, Tuna" plan lacked a critical control point for refrigerated storage to control histamine. The "Cooked Lobster, Crab and Shrimp" plan omitted a critical control point for cooling after cooking. 3. **Insufficient Critical Limits (21 CFR 123.6(c)(3)):** The "Cooked Lobster, Crab and Shrimp"