FDA issues warning letters to seafood processors and importers

Seafood processors without compliant seafood Hazard Analysis and Critical Control Point plans and dairy farms that sold animals that had illegal drug residues were among some the first warning letters released in 2016 by the U.S. Food and Drug Administration (FDA). The FDA has the power to detain the company’s shipments at the U.S. border unless the issues are addressed in a timely manner.

The four letters went out to seafood processors in Bronx, N.Y., and Yian, Taiwan, and to dairy farms in Mechanicsburg, Ohio, and Buckeye, Ariz.

FDA’s review of Hsien-Pin Frozen Foods Co. Ltd. in Taiwan began with an inspection Sept. 24-25, 2015.  FDA inspectors observed serious seafood HACCP violations and informed the company. It responded by submitting a HACCP plan for “Frozen, Raw, Ocean Harvested Mahi mahi, Wahoo, steaks or fillets.”

“Our review of the documentation determined that the response was not adequate, as further described in this letter,” says the FDA’s Jan. 14 warning letter. The agency said failure of a processor of fish and fishery products to have and implement a compliant plan means its products are “adulterated.”

“Accordingly, your mahi mahi and wahoo products are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health” FDA’s warning said.

The agency detailed a list of “significant deviations” in the warning, including the failure to implement controls for scombrotoxin (histamine) formation, temperature controls, and transportation issues.

The FDA has the power to detain the company’s shipments at the U.S. border unless the issues are addressed in a timely manner.

A similar warning letter, this one dated Jan. 19, was sent to Monte’s Seafood Emporium, Inc. in the Bronx.

That letter also carries a list of corrective actions with a focus on temperature and transportation issues. FDA wants a response from Monte’s within 15 days, saying: “You should include in your response documentation, such as HACCP and importer verification records, and records that document the performance and results of your firm’s affirmative steps, or other useful information that would assist us in evaluating your corrections.”

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