Zimmerman, Mark S. – FDA Warning Letter

On January 25, 2011, the FDA inspected Mark S. Zimmerman Farm, a dairy operation in Martinsburg, Pennsylvania. The inspection revealed multiple violations of the Federal Food, Drug, and Cosmetic Act.

A bob veal calf sold for slaughter on March 1, 2010, was found to have flunixin in its liver at 0.121 ppm, for which FDA has no established tolerance in veal calves. This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The farm also held animals under insanitary conditions, failing to maintain complete treatment records, which could lead to medicated animals with harmful drug residues entering the food supply, thus adulterating food under section 402(a)(4).

Furthermore, the new animal drug Flunazine (flunixin meglumine) was used extralabelly on the bob veal calf without following approved labeling for the animal class and without the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a) and resulting in an illegal residue, violating 21 C.F.R. 530.11(c). This caused the drug to be unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act.