FDA WARNING_LETTER - Dean Blanchard Seafood, Inc. - November 02, 2010

On October 26 and November 2, 2010, the FDA inspected Dean Blanchard Seafood, Inc.'s facility in Grand Isle, Louisiana, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice regulation (21 CFR Part 110). These violations render the firm's fish products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Specific violations include: 1. Failure to implement the record-keeping system listed in the HACCP plan, specifically not maintaining harvest vessel records at the receiving critical control point for scombrotoxin-forming fish (21 CFR 123.6(b)). 2. The HACCP plan for "King Mackerel, Amberjack, Bar Jack, Wahoo, Mahi-mahi" lacks critical limits for sensory examination and internal temperature at the receiving critical control point to control scombrotoxin formation (21 CFR 123.6(c)(3)). FDA recommends sensory examination (no more than 2.5% decomposition) and internal temperature monitoring (at or below 40°F). 3. The HACCP plan for "King Mackerel, Amberjack, Bar Jack, Wahoo, Mahi-mahi" does not list cooler storage as a critical control point