Middlebury Large Animal Clinic – FDA Warning Letter, Oct 28, 2011

On October 19 and 28, 2011, FDA investigators inspected Middlebury Large Animal Clinic, identifying violations related to extralabel drug use. The clinic prescribed sulfamethoxazole and trimethoprim tablets extralabelly for a calf without meeting the requirements of 21 CFR Part 530, rendering the drug unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act.

Specifically, the prescription lacked adequate labeling information required by 21 CFR 530.12(c) and (e), including directions for use (animal identification, condition, dosage, frequency, route, duration) and the veterinarian's specified meat withdrawal time. Furthermore, the clinic failed to comply with 21 CFR 530.20(a)(2)(iv), which mandates measures to ensure withdrawal timeframes are met and no illegal residues occur in food-producing animals treated extralabelly, especially since no tolerance for sulfamethoxazole residues in cattle exists.

The FDA acknowledged the clinic's stated implementation of new policies but found the response lacked sufficient detail. The clinic must provide a written response within fifteen working days, detailing corrective actions taken or planned to prevent recurrence, including supporting documentation. Failure to comply may result in regulatory actions like seizure or injunction.