FDA WARNING_LETTER - Plenus Group Inc. - March 02, 2012

On March 22, 2012, the FDA issued a Warning Letter to Plenus Group Inc. following an inspection of their seafood processing facility in Lowell, MA, from February 8 to March 2, 2012. 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 refrigerated clam chowder in reduced oxygen packaged bags was adulterated because it was prepared, packed, or held under insanitary conditions. Key violations included:

1. **Inadequate HACCP Plan - Critical Control Points (CCPs):** The HACCP plan for Ready-to-Eat Refrigerated Soups failed to list CCPs for: * Controlling *Clostridium botulinum* and toxin formation during the manufacturing process. * Controlling *Clostridium botulinum* growth and toxin formation at Finished Product Storage. * Metal detection to control metal fragments. * Container sealing to control reintroduction of bacteria.

2. **Inadequate HACCP Plan - Critical Limits:** The HACCP plan failed to list adequate critical limits: * The cooking critical limit ("Product must be cooked to at least (b)(4) F" and "held at that temperature