FDA EIR - Keith DeDonder, DVM, Dip. ACPV - October 04, 2016

An FDA inspection of Kieth DeDonder, DVM, Dip. ACPV, a clinical investigator associated with Veterinary and Biomedical Research Center Inc., was conducted from October 3-4, 2016. This premarket data audit, requested by the Center for Veterinary Medicine (CVM), aimed to evaluate compliance with clinical investigator regulations (CP 7348.811) and Good Clinical Practice guidelines (VICH GL9, Guidance Document 85) for a specific animal study. Notably, no FDA Form 483 was issued at the conclusion of this inspection, indicating a general adherence to regulatory standards. However, one key discussion item was raised concerning the facility's Standard Operating Procedures (SOPs). Inspectors identified that SOP 5803.02, outlining the euthanasia procedures for cattle and porcine, was not being fully followed. The SOP specified a primary euthanasia method involving a captive bolt, or alternatively, a gunshot. The facility, lacking a captive bolt device, performed euthanasia via gunshot, which was listed as an appropriate alternative in the SOP but not the primary method, and the SOP needed to reflect current practice more accurately. Other points discussed with management included challenges in confirming animal ages according to protocol requirements based solely on weight, the unknown antimicrobial treatment history of study animals purchased at auction (though this was deemed consistent with industry practice and the 'known' exclusion criteria), and the absence of animal disposition records. An instance of a sample shipment delay was also noted but confirmed by the laboratory to have no impact on sample integrity. The primary suggested action was for Dr. DeDonder's facility to update its SOPs to precisely align with actual operational practices. Management received a general reminder about their responsibilities under the Food, Drug and Cosmetic Act.