Blount Seafood Corporation – FDA Warning Letter, Dec 6, 2011

On January 13, 2012, the FDA issued a Warning Letter to Blount Seafood Corporation following inspections from November 17 to December 6, 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). Consequently, their retail and bulk, refrigerated modified atmosphere seafood soups were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations included: 1. **Inadequate Hazard Analysis and HACCP Plan (21 CFR 123.6(a) and (c)(2)):** The HACCP plan for Bulk and Retail Soups failed to list critical control points for controlling *Clostridium botulinum* (C. Bot) and other pathogens during manufacturing and for finished product labeling. Specifically, modified atmosphere packaged frozen products lacked a "keep frozen" statement on labels. 2. **Insufficient Critical Limits (21 CFR 123.6(c)(3)):** The HACCP plan for fresh seafood bulk and retail soups listed an inadequate critical limit for controlling C. Bot and other pathogens at certain control points. 3. **Deficient Monitoring Procedures (21 CFR 123.6(c)(4)):**