FDA WARNING_LETTER - Dawn's Foods, Inc. - February 22, 2011

On February 14-22, 2011, an FDA inspection of Dawn's Foods, Inc. seafood processing facility in Portage, Wisconsin, revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and current Good Manufacturing Practice (GMP) regulation (21 CFR Part 110). Consequently, products like Alaskan Krab Salad, Deluxe Seafood Salad, Tuna Macaroni Salad, Tuna Salad, Cajun Krab Dip, and Smoked Salmon Dip are deemed adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions.

Significant violations include: 1. **Inadequate Hazard Analysis and HACCP Plans:** HACCP plans for several products failed to list *Clostridium botulinum* growth and toxin formation as a reasonably likely food safety hazard at critical control points, despite products being packaged in large, deep containers (e.g., 5 lb). FDA recommends secondary control strategies like pH control (≤5.0), water phase salt (≥5%), water activity (≤0.97), or maintaining products at ≤38°F with time/temperature indicators. 2. **Insufficient Critical Limits:** Critical limits in HACCP plans for Alaskan Krab Salad, Seafood Salad, Cajun Krab Dip, Smoked Salmon Dip, Tuna Salad, and Tuna Macaroni Salad were inadequate to