FDA EIR - Covance Laboratories, Inc. - March 13, 2020

A routine Good Laboratory Practice (GLP) inspection of Covance Laboratories Inc. in Greenfield, IN, was conducted by the FDA from March 9-13, 2020. This unannounced surveillance inspection, initiated at the request of the Center for Biologics Evaluation and Research (CBER), adhered to Compliance Program 7348.808 for nonclinical laboratories. The inspection encompassed a review of test facilities, operations, test and control article handling, study practices, and data control related to investigational new drug (IND) and premarket submissions.

While no FDA Form 483 (Inspectional Observations) was issued, the inspection identified two areas for discussion with management. These included an unlabeled bottle found in the clinical pathology storage room and the presence of apparent organic growth on transfer boxes containing test articles in a dose analysis refrigerator. Covance Laboratories Inc. demonstrated a responsive approach, promptly addressing and correcting both items before the inspection concluded. The unlabeled bottle was disposed of, and the affected transfer boxes were removed and replaced, indicating the facility's proactive compliance.