FDA WARNING_LETTER - P & D Seafood Company Inc - September 27, 2013

On March 26, 2014, the FDA issued a Warning Letter to P & D Seafood Company Inc. following an inspection from September 25-27, 2013. The inspection revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice regulations (21 CFR Part 110).

The FDA determined that the firm's canned raw scallops and canned pasteurized crab meat were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Key violations included: 1. **Inadequate Critical Limits:** The HACCP plan for "Canned Raw Scallops" had an inadequate critical limit at the receiving critical control point to control *Clostridium botulinum* toxin formation. The FDA recommends maintaining temperatures at or below 38°F for the entire transit period, especially for products like raw scallops in cans that lack secondary barriers to control toxin formation. The firm's scallops are transported extensively without adequate records to ensure proper temperature control, and the product lacks barriers other than refrigeration. 2. **Inappropriate Corrective Actions:** The corrective action plans for "Canned Raw Scallops" and "Canned Pasteurized Crabmeat" at the receiving critical control point were inappropriate