CONTENT: Although the warning letter to Honolulu Fish Co. was just made public this past week by the FDA, it was actually sent out in November 2006. The company addressed the issues and FDA closed out the warning process related to the Nov. 28, 2006, letter in June of 2014. Food Safety News regrets any confusion caused by this reporting error.

A dairy operation in Illinois and a seafood processor in Hawaii were on the receiving end of warning letters from the Food and Drug Administration according to the agency’s most recently published records.

Potthast Farm, Avistin, IL
The FDA’s Chicago District Office notified partners Gerald Potthast and Eugene Potthast they had violated federal law by selling a cow for slaughter for human food that had more than 240 percent the allowable level of the antibiotic Desfuroylceftiofur in its tissue.

“The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of Desfuroylceftiofur at a level of 1.367 ppm. FDA has established a tolerance of 0.4 ppm for residues of Desfuroylceftiofur in the edible tissues of cattle,” according to the Dec. 5 warning letter.

“Our investigation also found that you hold animals under conditions that are inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4).”

Honolulu Fish & Seafood Corp. dba Honolulu Fish Co.
Dates have been corrected: On Nov. 28, 2006, the FDA’s San Francisco District Office notified company president Wayne Samiere that an August inspection of the seafood processing facility found “significant violations” of federal food laws. Specifically, the facility did not have an adequate HACCP plan (Hazard Analysis and Critical Control Point plan) to control growth of Clostridium botulinum toxin, which causes botulism poisoning.

“… your firm does not have HACCP plans for your refrigerated vacuum-packaged scombroid toxin forming species, such as mahi-mahi, and your refrigerated vacuum-packaged non-scombroid fish such as mako shark, to control the food safety hazard of Clostridium botulinum toxin formation,” according to the warning letter.

“Intermittent checks of the chiller air temperatures are not adequate for extended refrigerated hold times because they do not ensure that proper refrigerated temperatures were maintained between temperature checks. We recommend that in order to ensure maintenance of proper refrigeration temperatures, processors adopt methods that provide a continuous recording of refrigerated temperatures during refrigerated storage, e.g., recorder thermometer with a visual check of the instrument at least once per day.”

The FDA also noted that the company should be testing for the toxin and requesting records related to the harvest of the fish it is processing because “sensory evaluation” is not adequate to ensure food safety.

FDA sent a close-out letter to the company in June 2014, almost eight years after the warning letter was sent, indicating that the food safety issues cited in November 2006 had been adequately addressed. The 2006 warning letter was included in the agency’s “recently posted” warning letters this past week.

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