Old Point Packing, Inc – FDA Warning Letter, Jun 17, 2011

On October 17, 2011, the FDA issued a Warning Letter to Old Point Packing, Inc. following an inspection from June 14-17, 2011. 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 Scombrotoxin-forming finfish were adulterated because they were prepared, packed, or held under insanitary conditions. Key violations included:

1. **Inadequate HACCP Plan Critical Limits:** The HACCP plan for histamine-forming finfish listed critical limits for "Internal fish temperatures must be 40°F or below" at Receiving from Truck, Receiving from Vessel, and Storage critical control points, which were deemed insufficient to control Scombrotoxin formation. The FDA provided specific recommendations for adequate controls.

2. **Failure to Implement Monitoring Procedures:** The firm did not follow its own HACCP plan's monitoring procedures for "Ice coverage" and "Internal fish temperature" at the Receiving from Vessel and Storage critical control points. Specific instances cited included Boston Mackerel and Bluefish received on various dates where temperatures were not taken or ice adequacy not verified.

3. **Failure to Take Corrective Actions:** The firm did not take appropriate corrective actions when