FDA WarningSeafood 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. 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 that 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. “Accordingly, your ‘Pasteurized Ready-To-Eat Crab Meat,’ ‘Frozen Vacuum Packed Yellowtail Snapper,’ and ‘King Mackerel’ are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health,” the warning letter sent to Monte’s says. 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.” FDA sent a Jan. 13 warning letter to Ohio dairy farmer John D. Ayars related to meat he sold for human consumption. The meat testied positive for illegal drug residue. The warning concerned a cow sold for slaughter as human food on March 18, 2015. Animal antibiotics ciprofloxacin and gentamicin residues were found in the kidney tissue of the cow in post mortem testing by USDA’s Food Safety and Inspection Service. FDA has zero tolerance for these drugs in meat for human consumption. “Therefore, the presence of these drugs in edible tissues from this animal in these amounts causes the food to be adulterated within the meaning of (the law),” according to the warning letter. A similar warning letter sent July 8, 2015, but just released to the public, went out to the Butterfield Dairy in Arizona. In this case, the post mortem testing found the presence of 0.05 parts per million (ppm) of the animal antibiotic ampicillin in the kidney. FDA has established a tolerance of 0.01 ppm for ampicillin in the uncooked edible tissue of cattle. FDA also said: “Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply.” The letter says the dairy fails to maintain adequate medical and veterinary records.   (To sign up for a free subscription to Food Safety News, click here.)