FDA WARNING_LETTER - Bobby Chez, Inc. - August 24, 2010

On August 10-24, 2010, the FDA inspected Bobby Chez, Inc.'s seafood processing facility in Cherry Hill, NJ, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). This renders their crab cakes (par-cooked and non par-cooked), seafood salad, lobster pot pies, lobster mashed potatoes, shrimp puffs, and coconut shrimp adulterated under 21 U.S.C. § 342(a)(4).

The firm failed to conduct a hazard analysis and implement HACCP plans for seafood salad, non par-cooked crab cakes, lobster mashed potatoes, lobster pot pies, shrimp puffs, and coconut shrimp to control hazards like pathogen growth, toxin formation (Clostridium botulinum, Staphylococcus aureus, Bacillus cereus), and undeclared allergens/sulfites (21 CFR 123.6(a), (b)). The firm's response was inadequate as no HACCP plans were provided for these products.

For par-cooked crab cakes, the HACCP plan's monitoring procedures for undeclared allergens at the labeling critical control point were insufficient (21 CFR 123.6(c)(1)). The revised HACCP plan also lacked critical control points for processing steps after opening pasteurized crabmeat containers to control pathogen growth and toxin formation (Staphylococcus aureus, Bacillus cereus),