FDA WARNING_LETTER - northern boulevard corporation - April 26, 2011

On July 7, 2011, the FDA issued a Warning Letter to Northern Boulevard Corporation dba Despana Brand Foods following an inspection of their wholesale distribution facility from April 18-26, 2011. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). Specifically, the firm's refrigerated, ready-to-eat, dry cured tuna (Mojama) and white anchovy fillets were deemed adulterated. Key violations included the failure to conduct a hazard analysis and implement a written HACCP plan for these products to control hazards like scombrotoxin formation and pathogen growth, as required by 21 CFR 123.6(a) and (b). Additionally, the firm's affirmative step for importing fish and fishery products was inadequate; foreign government sanitary certificates did not certify compliance with U.S. Seafood HACCP regulations (21 CFR 123.12(a)(2)(ii)). The FDA warned that failure to correct these issues could lead to refusal of admission for imported products, including detention without physical examination, product seizure, and injunctions. The firm was required to respond in writing within fifteen working days, detailing specific corrective actions, including revised HACCP plans and monitoring records, and providing timelines for any outstanding corrections. The letter emphasized the firm's responsibility to ensure full compliance with all applicable regulations.