FDA EIR - Labcorp Clinical Research Unit, Inc. - April 06, 2018

The FDA conducted an unannounced surveillance inspection of Covance Cru Inc (Madison, WI) from April 2 to April 6, 2018. This Clinical Bioequivalence Evaluation (BEQ) inspection, managed by CDER's Office of Study Integrity and Surveillance, focused on an In Vivo Bioequivalence compliance program, specifically reviewing a New Drug Application study. The inspection encompassed areas such as IRB approvals, informed consent, employee training, protocol adherence, adverse event reporting, and facility walk-throughs. While no significant regulatory violations were observed, leading to a "No Action Indicated (NAI)" classification and no formal FDA 483 observations, several areas for improvement were discussed with firm management. These included enhancing protocol detail regarding subject fasting, improving documentation for contacting missed study subjects, ensuring up-to-date key card access for restricted areas, and addressing an adverse event report and ongoing minor documentation errors. The company’s Associate Clinical Director acknowledged these items and committed to corrections for future studies. The FDA recommended an NAI classification with a re-inspection per Center request.