In a June 30 warning letter, FDA’s Denver District Office told Morwai Dairy LLC of Fort Lupton, CO, that violations of the federal Food, Drug, and Cosmetic Act were found during a four-day investigation of the operation in April.
Specifically, the agency stated that a dairy cow sold for slaughter as food on or about Jan. 20 was later found to have 2.04 parts per million (ppm) of defuroylceftiofur, an antibiotic, in the kidney tissue and 0.673 ppm of flunixin, an anti-inflammatory drug, in the liver tissue.
Dairy cowsHowever, FDA has established a tolerance in cattle of 0.4 ppm for residues of desfuroylceftiofur in kidney tissue and 0.125 ppm for flunixin in liver tissue, the letter pointed out. The presence of these drugs at those levels causes the food to be adulterated, FDA added.
The warning letter also mentioned that the Morwai Dairy had failed to maintain written treatment records for a specific cow and that a signed affidavit had indicated that fresh pen treatment logs were being discarded after a certain period.
“Food from animals held under such conditions is adulterated …” under the Food, Drug and Cosmetic Act, the agency noted.
FDA’s Detroit Office sent a warning letter dated June 28 to Robin Martin of Snover, MI, regarding violations inspectors had identified while visiting his dairy operation on April 26, 28 and May 4.
A culled dairy cow sold for slaughter as food on or about July 28, 2015, was found to have desfuroylceftiofur (a marker residue for ceftiofur) at 5.48 ppm in the kidney tissue, the letter stated, although the FDA tolerance level for residues of that drug in cattle kidney tissue is 0.4 ppm.
Further, the agency stated that the dairy failed to maintain treatment records and that expired animal drugs were found on-site. Food from animals held under such conditions is considered adulterated under federal regulations, FDA noted.
A written response from the dairy dated May 23 detailed several operational changes that were being implemented in response to the agency’s observations from the inspection. However, FDA found the response inadequate “due to the lack of documentation illustrating the inclusion of indications for use, dosage given, and route of administration into your record keeping practices.”
Recipients of FDA warning letters have 15 working days from receipt to respond with details of the procedures they have taken, or will take, to correct the current violations and prevent them from recurring.