FDA WARNING_LETTER - Vernon W. Zimmerman - December 20, 2013

The FDA conducted an investigation of Vernon W. Zimmerman's calf raising operation in East Earl, Pennsylvania, on December 5, 12, and 20, 2013. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act concerning the extralabel use and adulteration of new animal drugs and animal feed. Specifically, the firm failed to use Neo-Sol 50, Baytril 100, and Oxytet as directed by their approved labeling, constituting extralabel use. This extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a). Furthermore, Baytril 100 was used extralabelly in food-producing animals, which is prohibited by 21 C.F.R. 530.41(a)(10). The firm also adulterated animal feed by adding Neo-Sol 50 and Oxytet to milk fed to calves, a violation under section 501(a)(6) of the FD&C Act. These actions rendered the drugs unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act. The FDA requires prompt corrective action within fifteen working days, including a written response detailing steps taken to correct violations and prevent recurrence. Failure to comply may result in regulatory actions such as seizure or injunction.