FDA WARNING_LETTER - Riley, Jason - June 26, 2015

On May 29 and June 26, 2015, the FDA investigated Jason L. Riley's dairy operation in Argyle, Wisconsin, identifying violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved the sale of an adulterated heifer for slaughter on February 25, 2015. USDA/FSIS analysis of liver tissue from this animal, identified with backtag #(b)(4), revealed sulfamethazine at 1.54 ppm, exceeding the FDA tolerance of 0.1 ppm (21 CFR 556.670). This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Additionally, the investigation found that animals were held under insanitary conditions, making it likely that medicated animals with harmful drug residues could enter the food supply. Specifically, Mr. Riley failed to maintain treatment records for medicated animals and did not keep records of animal purchases and sales for slaughter. These conditions constitute adulteration under section 402(a)(4) of the FD&C Act.

Mr. Riley is required to take prompt action to correct these violations and establish procedures to prevent recurrence. Failure to comply may result in regulatory actions like seizure or injunction. A written response detailing corrective steps, including documentation, is due within 15 working days of receiving the letter. If corrections cannot be completed