FDA WARNING_LETTER - NOC Management Co. Inc. - September 16, 2010

On December 15, 2010, the FDA issued a Warning Letter to NOC Management Co. Inc. following an inspection from September 14-16, 2010. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). These violations render the firm's fish and fishery products, including vacuum-packed and histamine-forming fish, adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Lack of HACCP Plan for *Clostridium botulinum***: The firm lacks a HACCP plan to control *Clostridium botulinum* growth and toxin formation in vacuum-packed fish thawed under refrigeration in intact packaging. 2. **Inappropriate Corrective Actions**: The HACCP plan's corrective actions for histamine-forming fish are inadequate. At receiving, re-icing temperature-abused fish or random product testing will not mitigate elevated histamine levels or correct the cause of deviations. Similarly, at storage, re-icing and a single temperature check are insufficient. 3. **Inadequate Monitoring Procedures**: The HACCP plan for histamine-producing fish lists an inadequate monitoring procedure at the "Refrigerated Storage" critical control point. Checking for ice