FDA WARNING_LETTER - B&A; Seafood - October 11, 2012

On November 29, 2012, the FDA issued a Warning Letter to B&A Seafood following an inspection from September 28 to October 11, 2012. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice (CGMP) regulation (21 CFR Part 110), rendering their fish and fishery products adulterated.

Key HACCP violations included: - Failure to implement record-keeping for receiving temperatures at critical control points (CCPs) for Clostridium botulinum and histamine control. - Failure to implement monitoring procedures and frequencies for storage CCPs, with cooler temperatures frequently exceeding critical limits. - Inability to provide mandatory records (Cooler Temperature and Sanitation Forms) for FDA review. - Inadequate monitoring procedures and frequencies in HACCP plans for receiving and storage CCPs. - Lack of a HACCP plan for fresh crabmeat packaged in plastic tubs to control Listeria monocytogenes. - Failure to take appropriate corrective actions when critical limits were exceeded, and distributing affected products. - Inappropriate corrective action plans in HACCP plans, lacking sufficient detail for evaluation and cause correction.

CGMP violations included: - Failure to use adequate freezing and refrigeration to control Listeria monocytogenes in cold smoked vacuum-packed salmon. - Insufficient monitoring of