Charles River Laboratories Inc., Pathology Associates (PAI) – FDA EIR, May 28, 2015

An FDA surveillance inspection was conducted at Charles River Laboratories Pathology Associates, located in Frederick, MD, from May 27 to May 28, 2015. The facility is registered as a Nonclinical Laboratory, encompassing various industry codes related to in-vitro diagnostics, human and animal therapeutic biologics, biosimilar drugs, and medical devices in cardiovascular and orthopedic fields. The purpose of the inspection was surveillance, assessing the laboratory's operations in support of these regulated products. A thorough review of the company's processes related to nonclinical studies was performed by FDA investigator Cynthia A. Harris. Crucially, the inspection concluded with a "No Action Indicated" (NAI) classification. This signifies that no objectionable conditions or significant violations were found during the inspection, and therefore, no Form 483, which details observed deficiencies, was issued. Consequently, no specific regulatory actions or corrective measures were required from Charles River Laboratories Pathology Associates as a result of this inspection.