FDA WARNING_LETTER - sivertson fisheries inc. - May 06, 2011

On May 4-6, 2011, the FDA inspected Sivertson Fisheries Inc. dba Lake Superior Fish Company and found 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). These violations render the firm's pickled herring, air-packed ready-to-eat smoked fish products, and raw trout, whitefish, herring, and walleye fillets adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: 1. **Inadequate Sanitation Monitoring (21 CFR 123.11(b)):** Failure to sufficiently monitor pest exclusion, evidenced by 10 mice captured (Jan-Mar 2011), observed dead mice, and dead insects. 2. **Untimely Monitoring of Food Contact Surfaces (21 CFR 110):** Smelt dressing machines had debris from April 28, 2011, on May 4, 2011, and a loading tray had peeling, rough caulking. 3. **Failure to Correct Sanitation Deficiencies (21 CFR 123.11(b)):** Repeated FDA 483 observations of pests, uncorrected entry points, un