FDA 483 - University of Pennsylvania School of Veterinary Medicine (Penn Vet) - January 26, 2018

An FDA inspection of the University of Pennsylvania School of Veterinary Medicine (Penn Vet) non-clinical laboratory identified two significant observations. The facility's quality assurance unit was not sufficiently independent from the personnel directing and conducting studies. Additionally, several nonclinical laboratory studies were not conducted in accordance with their established protocols, including missed pain scores, unlisted anesthetic agents, and undocumented scoring systems.