FDA WARNING_LETTER - Prospect Enterprises, Inc. - August 27, 2014

On October 8, 2014, the FDA issued a Warning Letter to Prospect Enterprises, Inc. following an inspection from August 18-27, 2014, at their San Diego, CA, seafood processing and importer establishment. 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 fishery products, including canned crab meat, salmon, yellowtail, oysters, and clams, were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) because they were prepared, packed, or held under insanitary conditions.

Key violations included: 1. **Inadequate HACCP plan monitoring procedures:** The HACCP plan for "Refrigerated Vacuum Packed Raw or Ready to Eat Seafood Products (Non-Scombroid)" had an inadequate monitoring procedure at the Receiving critical control point (CCP#1) to control *Clostridium botulinum* growth and toxin formation, specifically regarding temperature monitoring for canned crab meat during transportation. The firm's proposed use of Time Temperature Indicators (TTIs) was deemed insufficient. 2. **Failure to implement monitoring procedures:** The firm did not follow its own HACCP plan's monitoring procedures for refrigeration of