FDA WARNING_LETTER - Rushing Waters Fisheries, LLC - May 01, 2017

The FDA conducted an inspection of Rushing Waters Fisheries, LLC in Palmyra, Wisconsin, from April 3 to May 1, 2017. Environmental samples collected during the inspection revealed the presence of Listeria monocytogenes in 14 swabs, with Whole Genome Sequencing confirming one strain. This finding led to the determination that the firm's seafood products are adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. The inspection also identified serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123) and Current Good Manufacturing Practice (CGMP) regulation (21 CFR 110). Specifically, the firm failed to monitor sanitation conditions and practices with sufficient frequency, as required by 21 CFR 123.11(b). Evidence included dripping condensate onto ingredients, a dirty apron contacting fish, improper cleaning methods causing cross-contamination, and damaged food-contact surfaces. Additionally, the firm did not comply with CGMP requirements under 21 CFR 110.35(a), citing damaged and pitted floors in processing areas. The FDA acknowledged the firm's June 1, 2017, response detailing corrective actions like re-cleaning, environmental swabbing, and planned floor repairs, but stated their adequacy would be assessed during the next inspection. The firm must provide a written response within 15 working days outlining specific, documented corrective and preventive actions, including a timetable for completion. Failure to comply may result in regulatory actions such as seizure or injunction, and re-inspection fees.