FDA EIR - PATH - April 01, 2024

An FDA inspection of Vet Path Services, Inc. in Mason, OH, was conducted from March 28 to April 1, 2016, under the regulatory framework of 21 CFR part 58 Good Laboratory Practice (GLP) regulations. The comprehensive surveillance inspection of this nonclinical histopathology firm identified one formal observation detailed in an FDA Form 483. The primary violation concerned the quality assurance unit's failure to ensure that deviations from approved protocols or standard operating procedures were properly authorized and documented. Specifically, the firm did not adhere to SOPs for study director communications and electronic record handling across multiple studies, and failed to mark copied documents as "Company Confidential" during the inspection.

Beyond the formal observation, nine discussion items were raised, highlighting areas for improvement. These included inadequate documentation of off-site pathologist involvement, safety concerns within the histopathology laboratory such as unventilated solvent fumes and inappropriate attire, a missing study slide, insufficient record-keeping for staining procedures, and the need for Principal Investigators to review and sign study documents. Other recommendations involved calibration stickers for equipment, better organization of archived study records, and establishing a formal investigation procedure for deviations. The company needs to address these issues to ensure full compliance with GLP standards.