July 15, 2024

Minnesota Lutefisk Manufacturer Gets FDA Warning Letter

Day Fish Company in Braham, Minnesota was inspected by the FDA from January 17 to January 23, 2017 and received a warning letter. The firm makes lutefisk from imported dried cod distributes pickled herring cutlets.


According to the letter, the inspection revealed “serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations (21 CFR), Part 123. hat means that fish or fishery products are adulterated. The refrigerated, ready to eat seafood products are adulterated “in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.”

The firm must conduct a hazard analysis for each kind of fish and fishery product they produce along with a written HACCP plan to control any food safety hazards. They do not have an HACCP plan for pickled herring products to control hazards that may include scombrotoxin formation, pathogen growth, and allergens. The plastic containers holding the herring product allow for a reduced oxygen environment conducive to Clostridium botulinum growth tea toxin formation as a result of time tan temperature abuse.

The company must have an individual who has successfully completed training in the application of HACCP principles to fish and fishery product processing who can develop an HACCP plan, reassess and modify the plan, and reassess and modify hazard analysis. And sanitation control records must document monitoring and corrections set out in 21 CRF 123.11. The firm also could not demonstrate that they are monitoring sanitation conditions and practices to assure conformance with Currant Good Manufacturing Practices. There were no sanitation records for the lutefisk manufacturing area and the firm did not have records for monitoring pests from 2012 through 2017.

The company has 15 working days from the date of the letter (March 16, 2017) to respond. They must identify procedures taken or will take to completely correct current violations and prevent similar ones.

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