FDA WARNING_LETTER - Rushing Waters Fisheries, LLC - May 08, 2013

On April 25, 26, 30, May 2 and 8, 2013, the FDA inspected Rushing Waters Fisheries, LLC's seafood processing facility in Palmyra, Wisconsin, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). These violations render their fresh trout, smoked trout fillets, smoked fish spreads, smoked salmon fillets, whole smoked salmon, marinated salmon fillets, and salmon burgers adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: 1. **Inadequate HACCP plans (21 CFR 123.6(c)(2)):** Plans for fresh and smoked trout fillets lacked a critical control point (CCP) for metal inclusion at the cutting step. Multiple smoked products and marinated salmon fillets lacked a CCP for undeclared allergens at packaging. Salmon burgers lacked a CCP for undeclared allergens and *Clostridium botulinum* toxin formation at packaging, specifically regarding "keep frozen" labeling. 2. **Missing critical limits (21 CFR 123.6(c)(3)):** HACCP plans for smoked fish spreads, smoked trout fillets, whole smoked salmon, and smoked salmon fillets had an inadequate critical limit for cooler storage ("MAX AIR TEMP OF (b)(4) F FOR (b)(4) HOURS