FDA WARNING_LETTER - Country Maid, Inc. - December 16, 2010

The FDA inspected Country Maid, Inc.'s food processing facility in Milwaukee, Wisconsin, on December 8, 13, 15, and 16, 2010, with additional label collection on May 4, 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 (CGMP) regulation (21 CFR Part 110).

The firm's Shrimp Pasta Salad, Seafood Supreme, and Crab and Shrimp Salad with Tomato Basil Dressing were deemed adulterated under 21 U.S.C. § 342(a)(4) due to insanitary preparation, packing, or holding conditions.

Significant violations included: 1. **Inadequate HACCP Plan Monitoring Frequency:** The HACCP plan for Fully Cooked Ready-to-Eat Fish and Shellfish Salads, Spreads, and Dips listed an insufficient monitoring frequency for the finished product cooler temperature critical control point. The plan stated "(b)(4)" and in practice, only "(b)(4)" documented temperatures were taken daily, supplemented by a third-party alarm company. FDA recommends continuous 24/7 monitoring with daily record and equipment checks. (21 CFR 123.6(c)(4)) 2. **Insufficient Sanitation Monitoring:** The firm failed to