FDA WARNING_LETTER - Foremost Foods International, Inc. - November 02, 2010

On January 25, 2011, the FDA issued a Warning Letter to Foremost Foods International, Inc. following an inspection from October 1 to November 2, 2010. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), specifically 21 CFR 123.12 for imported fish and fishery products.

Key violations include: 1. **Lack of Product Specifications and Affirmative Steps (21 CFR 123.12(a)(2)):** The firm failed to have product specifications for all imported fish products and lacked affirmative steps for all foreign suppliers to ensure processing compliance with HACCP. A submitted specification sheet was incomplete regarding hazards, and only one affirmative step for a single supplier was provided despite multiple suppliers. 2. **Inadequate HACCP Plan Monitoring Procedures (21 CFR 123.6(c)(4)):** The HACCP plan's monitoring procedures for receiving and storage critical control points (CCPs) were insufficient to control histamine formation and pathogen growth. The plan did not specify monitoring frequency, temperature acquisition methods, or responsible personnel. 3. **Inappropriate Corrective Actions (21 CFR 123.7(b)):** Corrective actions in the HACCP plan for receiving and storage CCPs were deemed inappropriate. At receiving, the plan