FDA WARNING_LETTER - Jerry Ethington Dairy - August 19, 2015

On August 17 and 19, 2015, the FDA inspected Jerry Ethington Dairy in Chandler, Arizona, and found violations of the Federal Food, Drug, and Cosmetic Act. The dairy offered for sale an adulterated animal for slaughter. Specifically, on February 18, 2015, a dairy cow sold for slaughter was found to have penicillin at 0.106 ppm in kidney tissue, exceeding the FDA tolerance of 0.05 ppm (21 C.F.R. 556.510(a)). This violates section 402(a)(2)(C)(ii) of the FD&C Act, deeming the food adulterated due to unsafe new animal drug residues.

Additionally, the investigation revealed insanitary conditions where medicated animals with potentially harmful drug residues could enter the food supply, such as the failure to maintain treatment records. This constitutes adulteration under section 402(a)(4) of the FD&C Act. The FDA requires prompt corrective action and procedures to prevent recurrence. Failure to comply within fifteen working days may result in regulatory actions like seizure or injunction. A written response detailing corrective steps and timelines must be submitted to CAPT Daniel Cline, Acting Director, Compliance Branch.