FDA WARNING_LETTER - Bill Idsinga Dairy - September 13, 2012

On September 5, 6, 11, and 13, 2012, the FDA inspected Bill Idsinga Dairy in Kerman, California, and found violations of the Federal Food, Drug, and Cosmetic Act. The dairy offered for sale an adulterated animal for slaughter as food. Specifically, on April 30, 2012, a dairy cow sold for slaughter contained penicillin at 0.49 ppm in kidney tissue, exceeding the FDA tolerance of 0.05 ppm (21 C.F.R. 556.510), rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Furthermore, the investigation revealed that animals were held under insanitary conditions, making it likely that medicated animals with harmful drug residues could enter the food supply. A specific deficiency noted was the failure to maintain complete treatment records, which constitutes adulteration under section 402(a)(4) of the FD&C Act.

The FDA requires prompt corrective action to address these violations and establish procedures to prevent recurrence. Failure to comply may result in regulatory actions like seizure and/or injunction. The dairy must respond in writing within fifteen working days, detailing steps taken or planned for correction and prevention. If corrections cannot be completed within this timeframe, the response must state the reason for delay and a new timeline. Documentation of corrections