FDA WARNING_LETTER - Wewoka Animal Hospital - March 04, 2019

The FDA conducted an investigation at Wewoka Animal Hospital on February 12, 27, and March 4, 2019, concerning drug prescribing practices. The investigation revealed that the practice caused the new animal drug, (b)(4) Injectable solution, to be unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act, respectively. This non-compliance stemmed from the practice's failure to adhere to the Extra-label Drug Use in Animals regulation, 21 C.F.R. Part 530, resulting in an adulterated animal being offered for slaughter. Specifically, the practice failed to maintain complete records for the extra-label use of (b)(4) (oxtetracycline and flunixin meglumine) as required by 21 C.F.R 530.5. Records for extra-label uses in a bull and a steer were incomplete, lacking details such as the condition treated, species, duration, number of animals, and withdrawal times. Furthermore, the firm's extra-label use of (b)(4) did not meet the requirements of 21 C.F.R. 530.20(a)(2)(ii), 530.20(a)(2)(iii), and 530.20(a)(2)(iv). Examples included treating a bull for Strangles and a steer calf for umbilical abscess with dosages exceeding label recommendations. Wewoka Animal Hospital must take prompt action to correct these violations and establish preventative procedures. A written response detailing corrective actions, timelines, and supporting documentation is required within fifteen working days. Failure to comply may lead to further regulatory actions, including seizure or injunction.