PATH – FDA EIR, Aug 14, 2012

An FDA inspection of Experimental Pathology Labs, a nonclinical research laboratory in Durham, NC, took place on August 14, 2012. The inspection was conducted under Compliance Program 7348.808, which governs Good Laboratory Practice for Nonclinical Laboratories. This assessment was initiated by the Division of Bioequivalence and Good Laboratory Practice Compliance within the FDA's Center for Drug Evaluation and Research.

The purpose of the inspection was to evaluate the firm's continued operation as a contract pathology lab for both government and commercial nonclinical laboratories. The inspection concluded with no deficiencies identified, and as a result, no Form FDA 483, Inspectional Observations, was issued. This positive outcome mirrors that of the previous inspection, which also found no regulatory non-compliance.

During the visit, the investigator reviewed various operational aspects, including the firm's organization chart, master schedule, standard operating procedure (SOP) matrix, and specific study protocols and reports for histopathology and other specialized services. No issues or observations were noted during this comprehensive review.

Although no violations were found, management was reminded of their ongoing responsibility to ensure full adherence to all Good Laboratory Practice regulations. Since no specific issues were identified, no particular corrective or required actions were mandated by the FDA in this report beyond this general reminder.