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FDA sends warning letters to New York seafood importers

Three New York seafood importers are on notice from the Food and Drug Administration for violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation in addition to several federal food safety rules.

The FDA sent the warning letters to the companies in July, August and November of 2017 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 injunctions.

Derby Paradise Inc., Rosedale, NY
Derby Paradise Inc. in Rosedale, NY, is on notice from the FDA because of significant deviations from the Seafood HACCP regulation for foods under the Federal Food, Drug, and Cosmetic Act (the Act). The firm imports fish and fishery products to their U.S. establishment.

Staff from the Food and Drug Administration inspected the Rosedale, NY, location of Derby Paradise Inc. on March 2 and March 17 of 2017. They discovered “serious violations” regarding the firm’s affected products, according to a July 21 warning letter.

“As an importer of fish or fishery products, you must operate in accordance with the requirements, … there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply,” according to the warning letter sent to company president, Juliana Allotey.

If upon inspection, the FDA does not find assurance that the imported fish or fishery products have been processed under conditions that are equivalent to domestic processor requirements, then the fish or fishery products will be adulterated under the Act, and will be denied entry.

“Your canned tuna fish in sunflower oil with pepper are adulterated in that it has been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health,” according to the warning letter.

“You must implement an affirmative step which ensures that the fish and fishery product(s) you import are processed in accordance with the seafood HACCP Regulation.”

First Choice E Trading Corp., Flushing, NY
In a Nov. 22 warning letter to First Choice E Trading Corp., staff from the FDA discussed the inspection of the firm’s Flushing, NY, establishment on June 8, 2017.

The firm is on notice from the FDA because of significant deviations from the Seafood HACCP regulation. The firm imports fish and fishery products to their United States facility.

“As an importer of fish or fishery products, you must operate in accordance with the requirements,” the warning letter states. “… there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply,” according to the warning letter sent to company president Ms. Jin Chung.

If upon inspection, the FDA does not find assurance that the imported fish or fishery products have been processed under conditions that are equivalent to domestic processor requirements, then the fish or fishery products will appear to be adulterated under the Act, and will be denied entry.

“Your frozen bigeye tuna, Thunnus obesusare adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health,” according to the warning letter.

FDA inspectors noted the following significant violations.

The firm failed to implement an affirmative step that ensures the fish products it imports are processed in accordance with the Seafood HACCP Regulation.

In addition, the FDA acknowledged a response from the firm, however, “We have reviewed your response to the FDA 483 issued to your firm on June 8, 2017. Your response is not adequate because the documentation submitted with your response, including the certificates, do not provide assurance that the fishery products you import are processed in accordance with the requirements of the U.S. FDA seafood HACCP regulation.”

FDA officials warned that they may pursue additional enforcement actions if the firm does not promptly correct these violations.

“For instance, we may take further action to refuse admission of your imported fish or fishery products, including placing them on ‘detention without physical examination,’ seize your products and/or enjoin your firm from further violating the Act,” the FDA warned.

KBF INC., Astoria, NY
KBF Inc. in Astoria, NY, is on notice from the FDA because of significant deviations from the Seafood HACCP regulation, under the Act. The firm imports fish and fishery products to their United States facility.

According to the Aug. 16 warning letter, the FDA discovered and documented problems during an inspection on April 3 and 4 at the company’s establishment in the United States.

“Your Kaski dried fish, Faisha Chapa dried fish, and Puthi Chapa dried fish are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health,” according to the letter.

Upon inspection, the FDA observed the following significant deviations:

  • The firm failed to perform an affirmative step for their Kaski dried fish, Faisha Chapa dried fish, and Puthi Chapa dried fish; and
  • On March 21, 2017, the FDA collected a sample of Faisha Chapa dried fish that they offered for import. FDA laboratory analysis found these products to be uneviscerated and to measure greater than five inches in length. “FDA considers uneviscerated fish that are salt-cured, dried, or smoked and that are greater than five inches in length to represent a potentially life-threatening health hazard.”

Additionally, the FDA noted a May 31, 2017, response letter from the firm, saying it was “not adequate because it did not list the specific affirmative step you are performing nor did it include documentation of your performance of an affirmative step.”

FDA officials warned that they may pursue additional enforcement actions if the firm does not promptly correct these violations.

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