FDA WARNING_LETTER - Shirk, Clarence W, - April 17, 2008

On April 17, 2008, the FDA inspected Clarence W. Shirk's dairy operation at 353 Berry Lane, Beavertown, Pennsylvania, and found violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on or about August 14, 2007, Shirk sold a bob veal calf for slaughter. USDA/FSIS analysis of tissue samples from this animal, slaughtered on August 15, 2007, identified the presence of [redacted] at [redacted] ppm in the kidney tissue. FDA has not established a tolerance for [redacted] residues in veal calves, rendering the food adulterated under section 402(a)(2)(C)(ii) of the Act [21 U.S.C. § 342(a)(2)(C)(ii)].

Additionally, 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. An example cited was the failure to maintain complete treatment records. This constitutes adulteration under section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)].

Shirk is responsible for ensuring compliance and must take prompt action to correct these violations and prevent recurrence. Failure to do so may result in regulatory actions such as seizure and