FDA EIR - PATH - April 01, 2016

An FDA Good Laboratory Practice (GLP) Surveillance inspection of Vet Path Services, Inc. in Mason, OH, was conducted from March 28 to April 1, 2016. The inspection, performed under 21 CFR Part 58 GLP regulations for nonclinical laboratories, assessed the firm's histopathology operations. The inspection resulted in a single formal observation on FDA Form 483, identifying the Quality Assurance Unit's failure to ensure that all deviations from approved protocols or standard operating procedures were properly authorized and documented. Specific issues included the absence of filed email correspondence with study directors in study records and the non-marking of documents as 'Company Confidential' during the inspection, contrary to the firm's own procedures. Furthermore, nine discussion items highlighted additional areas for improvement. These included missing correspondence for off-site pathologists, several safety concerns in the histopathology laboratory (e.g., fume hood operation, lack of nearby safety shower, inappropriate personal protective equipment), inadequate quality control checks for items in temporary storage, and disorganized archived study records. Recommendations also involved enhancing documentation for control slide staining times, retraining principal investigators on reviewing study documents, and formalizing investigation procedures for processing errors. Vet Path Services, Inc. is required to implement corrective actions to address the formal observation, ensuring stronger Quality Assurance processes and adherence to GLP standards, and to consider the suggested improvements for operational excellence.