FDA WARNING_LETTER - Sivertson Fisheries Inc - January 28, 2010

On January 27-28, 2010, 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 regulation (21 CFR Part 110). These violations render the firm's pickled herring and air-packed, ready-to-eat smoked fish products adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

The significant violation identified was the firm's failure to conduct a hazard analysis and implement written HACCP plans for its products, as required by 21 CFR 123.6(a) and (b). Specifically, the firm lacked a HACCP plan for ready-to-eat Pickled Herring to control scombrotoxin (histamine) formation and pathogen growth. Additionally, there was no HACCP plan for ready-to-eat smoked fish, including Smoked Lake Herring (Cisco and/or Tullibee), to control pathogen growth.

The FDA warned that failure to promptly correct these violations could lead to further action, including product seizure and/or injunction against the firm's operation. Sivertson Fisheries Inc. was required to respond in writing within 15 working