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Nine days in March shows FDA is busy with warning letters

Sunday, April 9, 2017 21:33
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Food and Drug Administration warning letters sent out from March 15 to 24, 2017 show the agency continues to target a multitude of practices that it finds  not in compliance.

On March 15, FDA sent a warning letter to Country Favor Inc. in Maspeth, NY over the seafood importer’s “serious violations” of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.

It said importers of fish or fishery products must process under conditions that “are equivalent to those required of domestic processors.” Country Flavor’s ready-to-eat Salted Mackerel, Salted Gourmay, and Salted Mud Fish were found to be adulterated for being prepared, packed, or held under insanitary conditions.

FDA warned the company to adhere to seafood HACCP regulations or risk having its products detained at the U.S. borders without physical examination.

On March 16, FDA sent a warning letter to Nobel Bakery Inc. located in North Hollywood, CA for serious violations of the Current Good Manufacturing Practice (CGMP) regulation for food.

The 7-page warning letter provides the North Hollywood bakery with detailed instructions on what it must do to become compliant with necessary regulations.

It says Nobel Bakery is manufacturing in insanitary conditions that are not following CGMP regulation for food. The problems include both failure to maintain buildings, fixtures, and other physical equipment and failure to control pests in processing areas and to protect against food contamination by pests.

On March 22, FDA sent a warning letter to H&W Farms, LLC at Belding, MI. The letter concerns juice products produced by H&W that FDA found to be adulterated. It said the farm was not following the juice HACCP regulations.

FDA has ordered H&W to develop a hazard analysis for each juice it processes to identify any food hazard that is reasonably likely to cause illness or injury be it from a biological, chemical or physical agent.

The warning letter said H&W does not have an HACCP plan for cherry juice concentrate. The farm currently does not monitor the sanitation of juice bottling and pest activity in the production area, according to the FDA warning letter.

On March 23, FDA sent a warning letter to another seafood importer, Daesang America Inc. in Hackensack, NJ. It too was cited for “serious violations” of seafood HACCP regulations.

“If assurances do not exist that imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors…” the warning letter said the products will be denied entry to the U.S.

The New Jersey company imports frozen fish cakes. FDA said it must provide written verification procedures. Also it must maintain sufficient records to document performance and results of “affirmative steps.”

Finally, on March 24, FDA sent a warning letter to KC Innovations. Inc. in Mission, KS. It concerned the company’s acidified food processing facility in Kansas City, Mo.

KC Innovations was cited for failing to file a schedule process under the regulations for processing acidified food products including eight different products including various cheese dips and fondues.

The warning letter also said KC failed to “maintain instruments used for measuring, regulating and recording conditions that control the growth of microorganisms, as required…”

FDA warning letters typically give food companies 15 working days to respond to the concerns raised by the agency.

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Source: http://www.foodsafetynews.com/2017/04/nine-days-in-march-shows-fda-is-busy-with-warning-letters/

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