FDA WARNING_LETTER - United Fish Distributors, Inc. - July 27, 2009

On November 19, 2009, the FDA issued a Warning Letter to United Fish Distributors, Inc. following an inspection from July 15-27, 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 (CGMP) regulation (21 CFR Part 110).

The FDA determined that the firm's fish and fishery products, including Pasteurized Canned Crabmeat, were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)) due to preparation, packing, or holding under insanitary conditions.

Significant violations included: 1. **Inadequate HACCP Plan (21 CFR 123.6(c)(4)):** The "SEAFOOD SUBJECT TO CLOSTRIDIUM BOTULISM" HACCP plan (dated 5/4/2009) had an insufficient monitoring procedure at the receiving critical control point for Pasteurized Canned Crabmeat, failing to adequately control *Clostridium botulinum* growth and toxin formation during extended transit. The FDA recommended continuous time/temperature monitoring or ice adequacy checks upon receipt. 2. **Insufficient Sanitation Monitoring (21 CFR