FDA EIR - Experimental Pathology Laboratories, Inc. - November 13, 2018

The FDA conducted an unannounced Good Laboratory Practice (GLP) inspection of Experimental Pathology Laboratories, Inc. (EPL, Inc.) in Sterling, VA, from November 7 to November 13, 2018. This inspection, carried out under Compliance Program 7348.808 for non-clinical laboratories involved in human drug studies, reviewed the company's facilities, personnel, Quality Assurance Unit (QAU), and histopathology operations. EPL, Inc. serves as a contract laboratory providing histopathology and necropsy services for non-clinical studies supporting drug, biologic, animal drug, food additive, and medical device applications, thus operating under GLP regulations.No formal inspectional observations (FDA-483) were issued. However, two critical general practice items were discussed with management. The first involved an unauthorized employee briefly entering the archive room without proper sign-in, with the security door left open, indicating a potential breach of the firm's Standard Operating Procedures (SOP 8.2) for archive access. The second concern addressed the independence of the Quality Assurance Unit; SOP 6.2 indicated QAU reports were submitted to "management" without clear delineation, while the company President also acted as a Principal Investigator on regulated studies. Although management confirmed QAU reports currently go to the Chief Financial Officer, ensuring separation, the SOP required updating.EPL management committed to immediate corrective actions, including retraining the employee on archive protocols and revising the QAU reporting SOP to formalize independence from personnel involved in studies.