FDA EIR - PATH - September 20, 2007

An FDA Good Laboratory Practice (GLP) surveillance inspection was conducted at Experimental Pathology Labs in Durham, NC, on September 20, 2007. The primary objective was to assess the facility's adherence to GLP regulations, consistent with a prior inspection in 2004. Experimental Pathology Labs functions as a contract pathology laboratory, offering services such as histology, pathology, necropsy, and consultation for animal studies. During the inspection, the company was found to be operating in general compliance with regulatory requirements. No significant operational or facility changes were observed since the previous inspection. Crucially, the inspection concluded without the issuance of an FDA Form 483, "Inspectional Observations," signifying that no major violations or deficiencies were identified. Reviews of selected study records likewise revealed no discrepancies. As a result, no specific regulatory actions or corrective measures were required from Experimental Pathology Labs following this inspection.