An Iowa dairy, a Seattle sushi manufacturer and a lutefisk maker in Minnesota are all on notice from the Food and Drug Administration for violations of the federal Food, Drug & Cosmetic Act.

The FDA sent warning letters to each of the companies in March and posted them for public view in recent days. Companies are allowed 15 working days to respond to FDA warning letters. Failure to promptly correct violations can result in legal action without further notice, including, without limitation, seizure and injunction.

Day Fish Co. Inc.
In a March 16 warning letter of company owner and president Roy E. Bolling, the FDA described violations observed during an inspection from Jan. 17-23 at the Day Fish Co. Inc. in Braham, MN. The company manufactures lutefisk from imported dried cod and distributes pickled herring cutlets, according to the warning letter.

Seafood handlers, packers and manufacturers are required by federal law to comply with seafood Hazard Analysis and Critical Control Point (HACCP) regulations, which include maintaining temperature control, training employees and documenting cleaning and sanitization of facilities and equipment.

“Your firm does not have a HACCP plan for your pickled herring products to control food safety hazards which may include scombrotoxin — histamines — formation, pathogen growth, and allergens,” according to the warning letter.

“In addition, the plastic containers holding the herring products allow for a reduced oxygen environment conducive to Clostridium botulinum growth and toxin formation as a result of time and temperature abuse.

“During the inspection, we noted that you were not continuously monitoring the temperature for either the ready-to-eat herring or the lutefisk processing areas as required.

The FDA inspectors also noted dirty equipment and facilities at Day Fish Co. Inc., reporting that the company does not have a sanitation or cleaning schedule.

“Specifically, you could not demonstrate that you are monitoring the sanitation conditions and practices to assure conformance with Current Good Manufacturing Practices,” according to the warning letter.

“During the inspection, we noted that you did not have sanitation records for the lutefisk manufacturing area and did not have records for monitoring pests from 2012 through 2017.”

Brian J. Merges dairy
In a March 17 warning letter to dairy owner Brian J. Merges the FDA reported finding more than 10 times the legal limit of the antibiotic desfuroylceftiofur in edible tissues of a cow sold for slaughter as human food.

The Dec. 15, 2016, illegal sale of the cow was discovered during an inspection conducted Jan. 31-Feb. 1 by the Iowa Department of Agriculture and Land Stewardship on behalf of the FDA. Analysis of tissue from the cow also showed illegal levels of the non-steroidal anti-inflammatory drug flunixin. Tests showed more than 5.9 parts per million (ppm) of the desfuroylceftiofur, which is not to exceed 0.4 ppm, and flunixin levels of 0.3 ppm, which are not to exceed 0.1.

“Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain treatment records,” according to the warning letter.

Northwest Frozen LLC dba Banzai Sushi
In a March 20 warning letter to Philip K. Sinz, owner and managing member of Banzai Sushi in Seattle, described violations in every phase of the operation, including record keeping, cleaning, temperature control and poor hygiene practices of employees. The list of violations of the seafood HACCP regulations “renders the fish or fishery products adulterated” under federal law.

FDA inspectors discovered and documented the problems at the Seattle sushi production facility from Jan. 4-13. They found temperature logs showing fish that should be held at 38 degrees was found to be held at 40 to 45 degrees on multiple occasions.

“Vacuum-packaged product in which refrigeration is the sole barrier to outgrowth of non-proteolytic C. botulinum should be maintained below 38 degrees F,” according to the warning letter.

Filthy equipment and bad employee practices, such as handling trash cans and then handling ready-to-eat food without changing their gloves, are detailed in the warning letter. Employees also failed to wash their hands before handling food. The company also did not have cleaning and sanitizing schedules and dirt and food residue was found on multiple food contact surfaces.

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© Food Safety News

FDA warns two seafood firms, one dairy to clean up operations by: Pamela Hendrix published:

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