FDA EIR - Craig R Reinemeyer, DVM PhD - February 16, 2021

An FDA surveillance inspection of Craig R. Reinemeyer, DVM, located in Rockwood, TN, was conducted from February 5 to February 16, 2021. This comprehensive, in-life inspection was carried out under the Animal Drug User Fee Act (ADUFA) to assess compliance with regulations governing animal drug studies. The inspection focused on a specific ongoing clinical study involving purpose-bred beagle dogs. During the review of study records, including subject records, case report forms, investigational diet administration, and adverse event documentation, the inspector found no deficiencies. Specifically, the records were noted as generally organized, neat, and legible, with corrections properly documented. The administration of investigational diets was verified to be in accordance with the randomization scheme. No serious adverse events were reported or identified during the study period. As a result of these findings, the report indicated no objectionable conditions or main violations were identified, and consequently, no voluntary corrections or specific required actions were listed in the inspection report.