Dreisbach Enterprises Inc. – FDA Warning Letter, Aug 24, 2010

On November 2, 2010, the FDA issued a Warning Letter to Dreisbach Enterprises, Inc. following an inspection of their seafood processing facility and warehouse at 125 Salinas Road, Pajaro, CA, on August 13, 20, and 24, 2010. 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 FDA determined that the firm's fresh, refrigerated scombrotoxin-forming fish, such as Sardines and Mackerel, 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.

Specific violations included: 1. Failure to list Scombrotoxin (Histamine) formation as a food safety hazard at the Receiving critical control point in their HACCP plan for fresh, refrigerated fish, as required by 21 CFR 123.6(a) and (c)(1). The plan incorrectly listed "Degradation of product" instead. 2. Failure to take appropriate corrective action when critical limits were exceeded. On June 3, 2010, Mackerel was received at (b)(4)º