FDA WARNING_LETTER - C & S Wholesale Grocers, Inc - September 08, 2009

The FDA inspected C & S Wholesale Grocers, Inc.'s seafood processing facility in Hatfield, MA, from August 27 to September 8, 2009. 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 regulation (21 CFR Part 110).

The firm's refrigerated, ready-to-eat, pasteurized canned crabmeat was deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, due to being prepared, packed, or held under insanitary conditions.

Specific violations included: 1. Failure to implement monitoring procedures and frequency as listed in the HACCP plan (21 CFR 123.6(b) and (c)(4)). For instance, between January 6 and August 28, 2009, eight out of an unspecified number of crabmeat shipments were not temperature monitored at receiving, which is critical for controlling *Clostridium botulinum* growth. 2. Inadequate HACCP plan for refrigerated, ready-to-eat, pasteurized canned crabmeat, hot smoked salmon, and surimi (21 CFR 123.6(c)(4)). The plan's monitoring frequency at the receiving critical control point was insufficient to control pathogen hazards. It