The latest posted warning letters from the U.S. Food and Drug Administration (FDA) were sent to a seafood processing company and two dairies, all in the state of New York. FDA told Royal Seafood Baza Inc. of Staten Island, NY, in an Oct. 20, 2015, warning letter that “serious violations” of the seafood HACCP regulations were observed during an inspection of the facility from March 12-19 of this year. The agency’s letter noted there were inadequate assurances that the company’s salt-cured herring fillets packed in salt brine, salt-cured herring fillets packed in oil or vacuum-packaged, and caviar products had been processed in compliance with the seafood HACCP requirements. Royal Seafood Baza responded to FDA’s concerns in April with revised HACCP plans and a description of corrections to these concerns. FDA’s letter noted that response and stated that a hazard analysis for each kind of fish and fishery product must be done, and the company’s HACCP plan must list the food safety hazards “reasonably likely to occur.” “Your firm’s HACCP plan for ‘Receipt, Cold Storage, and Distribution of Caviar Products’ does not list the food safety hazard of Clostridium botulinum growth and toxin formation at the ‘Labeling of Finished Product’ critical control point, the agency stated, adding that time and temperature monitoring policies and practices needed to be improved both in the transporting and in the processing of its products. In an Oct. 19, 2015, warning letter, FDA informed Bellewood Farms of Woodville, NY, that an investigation of the dairy operation conducted on Aug. 25 and Sept. 1, 2015, found that a bob veal calf had been sold for slaughter as food on or about June 11, 2015. Subsequent tests found 9.1 parts per million (ppm) of neomycin residue in the kidney tissue, the agency stated. However, the FDA tolerance level is 7.2 ppm, but since there is no tolerance level for pre-ruminating calves (veal calves), the letter stated that “the presence of this drug in kidney tissue from this animal in this amount causes the food to be adulterated … .” The letter further noted that the dairy failed to maintain complete treatment records, did not use new animal drugs as directed by their approved labeling, did not follow the dose as stated and did not use them under the supervision of a licensed veterinarian, did not follow the route of administration as stated in the approved labeling, and failed to use medicated feed in conformance with its approved labeling. River Valley Dairy in Ellenburg Center, NY, was told in an FDA warning letter dated Oct. 19, 2015, that an investigation of the operation on Aug. 25 and Sept. 2, 2015, revealed that a bob veal calf sold for slaughter as food on or about June 9, 2015. An analysis of tissue samples from this animal identified the presence of neomycin at 16.34 ppm, while the tolerance level is 7.2 ppm, the agency stated. “However, this tolerance does not apply to the use of IBA Scour Treat 10g, (neomycin sulfate and oxytetracycline hydrochloride) in calves to be processed for veal (pre-ruminant calves), and there is no acceptable level of residue associated with the use of this drug in veal calves,” FDA’s letter stated. Additionally, FDA stated that the dairy failed to have a system in place to adequately segregate animals, failed to maintain treatment records, failed to adequately identify the animals that are transported and delivered for sale at an auction yard, and did not use animals drugs in an approved manner, on the lawful order of a licensed veterinarian, or in conformance with their approved labeling. Recipients of these warning letters have 15 working days from receipt to outline specific steps they have taken to come into compliance with the law.
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