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FDA warning letters: Plant problems, drug residues, seafood HACCP

Sunday, November 27, 2016 23:39
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The U.S. Food and Drug Administration’s most recently posted food-related warning letters went to a produce processing facility and a dairy in Michigan, an acidified food manufacturer in Japan, and a fish exporter in Ukraine.

The agency told Pearson Foods Inc. in an Oct. 26 warning letter that a June 14-27 inspection of its ready-to-eat cut fruit and vegetable processing facility in Grand Rapids, MI, revealed “significant violations” of Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food regulations.

FDA wrote that adequate floor drainage must be provided in all areas where normal operations release or discharge water or other liquid on the floor.

“However, we observed standing water during the production of shredded cabbage. There was food debris on the floor in the standing water and workers walked through the water. Standing water fosters harborage of pathogens such as Listeria monocytogenes,” the warning letter stated.

Other problems included pitted and eroded cement floors, which FDA noted was creating “a harborage for microorganisms,” and condensation on two metal plates and on a conduit wire above unprotected ready-to-eat coleslaw.

FDA also wrote that there were deep gouges along the entire length of the cutting table belt and also gouges intentionally cut into cutting boards to serve as a means of measurement, creating difficulties in keeping the surfaces clean and sanitary.

According to the warning letter, the company’s response stated that the cutting table belt and the floor were being replaced and that hose training would be implemented.

“We will evaluate the adequacy of your corrective action during our next inspection,” FDA stated.

A warning letter dated Nov. 15 was sent to Jack Van Drie notifying him that an investigation of his dairy operation in Marion, MI, on June 2 and 14 revealed violations of the Federal Food, Drug, and Cosmetic Act.

On or about Feb. 29, a dairy cow was sold for slaughter as food, and tissue samples from this animal identified the presence of oxytetracycline at 12.51 parts per million (ppm) in the kidney and flunixin at 0.35 ppm in the liver, according to the letter.

However, FDA’s established tolerance is 12 ppm for residues of oxytetracycline in the kidney of cattle and 0.125 ppm for residues of flunixin in the liver of cattle.

“The presence of these drugs in the edible tissues from this animal in these amounts causes the food to be adulterated …,” the agency stated. The warning letter also noted that the dairy operation failed to maintain complete treatment records.

A July 27-28 inspection of the Tokushima Seihun Co. Ltd. acidified food facility in Hyogo, Japan, revealed “serious violations” of the Emergency Permit Control and Acidified Foods regulations, according to a Nov. 7 warning letter from FDA.

FDA told the company that it must file scheduled processes for each acidified food in each container size to comply with federal regulations. These must include conditions for heat processing; control of pH, salt, sugar, and preservative levels; and source and date of the establishment of the process for each acidified food in each container size.

“Specifically, your firm did not provide FDA with the scheduled processes for your udon noodles, a product which our inspection revealed is an acidified food based on your process which is to add acid to the udon noodles to achieve a shelf stable hermetically sealed product,” according to the warning letter.

Other problems mentioned in the letter related to inadequate testing of pH values, insufficient container coding, no routine container testing, and not having specifically trained plant personnel at the facility.

The company’s response to these findings was found to be inadequate because requested process and procedure documents were not provided to FDA’s investigator during the inspection, the letter stated.

FDA sent a warning letter dated Nov. 7 to TOV “Universal Fish Company” in Kharkivska Oblast, Ukraine, detailing responses to the company’s HACCP plan which the agency obtained from an importer in New York.

This review revealed “serious deviations” from requirements of the seafood Hazard Analysis and Critical Control Point regulations, according to the letter.

“Accordingly, your herring products covered by your HACCP plan entitled ‘Herring in Oil’ are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health,” FDA wrote.

Specifically, the company’s HACCP plan entitled “Herring in Oil” does not list the food safety hazards of Clostridium botulinum growth and toxin formation, scombrotoxin (histamine) formation and allergens, according to the agency.

“Although your HACCP plan identifies the hazard of pathogenic microorganism including for example, Listeria monocytogenes and Salmonella, you have not identified the specific pathogen of concern, Clostridium botulinum, which is reasonably likely for products such as your products that are packaged in oxygen impermeable non-flexible pouches,” the warning letter stated.

“Also, as a scombroid species of fish, herring poses a hazard for scombrotoxin (histamine) formation as a result of time and temperature abuse. Additionally, your firm has potential allergenic substances listed in the ingredient statements for some of your herring products which pose a hazard that should be addressed,” FDA noted.

The company included a corrective action plan in its HACCP plan, but the agency responded that in order for the corrective actions to comply with federal regulations, they must address both the disposition of the affected products and the cause of the deviation.

“FDA recommends the corrective actions include holding the affected product (i.e., chilled) and evaluating the level of safety, based on the total cumulative time and temperature exposures at unrefrigerated/un-chilled conditions, including exposures at unrefrigerated/un-chilled conditions during processing. FDA also recommends the listed corrective actions address correcting the cause of the deviation by making repairs or adjustments to the cooler,” the warning letter stated.

Recipients of FDA warning letters have 15 working days from receipt to respond with details of the procedures they have taken, or will take, to correct the current violations and prevent them from recurring.

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