FDA WARNING_LETTER - Truman Sanner, DVM - December 10, 2010
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On December 7 and 10, 2010, the FDA investigated Dr. Truman R. Sanner's veterinary practice, Rocky Creek Veterinary Service, regarding drug use. The investigation found that Dr. Sanner caused the animal drug sulfadimethoxine to be unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act, respectively, due to extralabel use not conforming to approved uses or 21 CFR Part 530.
Specifically, Dr. Sanner verbally prescribed sulfadimethoxine to treat lactating dairy cattle for diarrhea, which is an extralabel use prohibited by 21 CFR § 530.41(a)(9). Additionally, even if not prohibited, Dr. Sanner failed to comply with 21 CFR 530.20(a)(2) by not making a careful diagnosis, evaluating conditions, or ensuring appropriate withdrawal times to prevent illegal drug residues. A culled dairy cow from a client was subsequently found to contain illegal drug residues in edible tissue.
The FDA requires Dr. Sanner to take prompt action to correct these violations and establish procedures to prevent recurrence. Failure to comply may result in regulatory action, including seizure or injunction. Dr. Sanner's December 20, 2010, response was deemed insufficient as it lacked detail on specific corrective actions, such as addressing extr
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