Noon Hour Food Products, Inc. – FDA Warning Letter, Apr 18, 2013

The FDA conducted an inspection of Noon Hour Food Products, Inc. from April 9-18, 2013, revealing serious violations of seafood HACCP (21 CFR 123) and GMP (21 CFR 110) regulations. The firm's herring products are deemed adulterated.

Violations include: 1. **Inadequate HACCP Plans (21 CFR 123.6(a) & (c)(2)):** HACCP plans for Marinated Herring in Sour Cream Sauce and Marinated Herring in Wine Sauce fail to list first and second brining as critical control points for histamine and pathogen control. FDA recommends monitoring brine and ambient air temperatures (at or below 40°F) and brine-to-fish ratio. 2. **Missing Critical Limits (21 CFR 123.6(c)(3)):** HACCP plans lack critical limits at the "filling" critical control point to control histamine and pathogen growth. While pH of mixing sauces is monitored, FDA recommends monitoring finished product pH to ensure it reaches 5.0 or below. 3. **Inappropriate Corrective Actions (21 CFR 123.7(b)):** Corrective action plans for the "Storage" critical control point for histamine are inadequate, lacking details on fish analysis quantity and histamine limits. They also fail to address pathogen growth and toxin formation, or actions to regain