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

University of Pennsylvania School of Veterinary Medicine (Penn Vet) – FDA 483, Jan 26, 2018

Record Details

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.

Company
University of Pennsylvania School of Veterinary Medicine (Penn Vet)
Inspection date
January 26, 2018
Product type
veterinary
Office
Philadelphia District Office
Person
  • Stephanie C. Mangigian (investigator)
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ID · 8a22a46f-052d-4f2e-8e95-b5317dad090f

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