FDA WARNING_LETTER - Van Deurzen Dairy, LLC - September 02, 2011

On October 25, 2011, the FDA issued a Warning Letter to Van Deurzen Dairy, LLC, following an investigation conducted on July 12, 14, August 30, and September 2, 2011. The investigation revealed significant violations of the Federal Food, Drug, and Cosmetic Act.

The primary violation involved the sale of an adulterated dairy cow for slaughter. Tissue samples from the animal, slaughtered on March 23, 2011, contained 0.43 ppm of penicillin in the kidney, exceeding the FDA tolerance of 0.05 ppm (21 C.F.R. 556.510). This rendered the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Furthermore, the dairy operation was found to be holding animals under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply. This was evidenced by a failure to maintain complete treatment records, violating section 402(a)(4) of the FD&C Act.

The FDA also cited the adulteration of the new animal drug, Penicillin Injection. The investigation found extralabel use of penicillin, specifically administering it to dairy cows without following the approved dose and duration. This extralabel use was not under the supervision of a licensed veterinarian (violating 21