FDA WARNING_LETTER - Country Maid, Inc. - July 20, 2011

On November 8, 2011, the FDA issued a Warning Letter to Country Maid, Inc. following an inspection of their seafood processing facility in Milwaukee, Wisconsin, from July 8 to July 20, 2011. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their Seafood Supreme, Tuna Salad, Tuna Penne Salad, Seafood Delight, Shrimp Pasta Salad, Crab and Shrimp Salad, and Seafood Dip adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: 1. **Inadequate Hazard Analysis:** The HACCP plan for "Fully Cooked Not Heat Treated Not Shelf Stable Ready to Eat Tuna Salads" failed to list *Clostridium botulinum* as a food safety hazard for finished products packaged in containers of 5 pounds or more, violating 21 CFR 123.6(a) and (c)(1). 2. **Insufficient Critical Limits:** The HACCP plan for "Fully Cooked, Not Heat Treated Not Shelf Stable Ready to Eat Surimi Salads, Spreads and Dips" listed an inadequate critical limit at a critical control point to control *Clostridium botulinum* when finished product is packaged in containers of 5 pounds or more, violating 21 CFR 123.6