FDA 483 - Cook Medical Incorporated - August 23, 2018

An FDA inspection of Cook Medical Incorporated in Bloomington, IN, an initial importer and contract manufacturer, revealed two significant observations. The firm failed to adequately establish procedures for corrective and preventive action, specifically regarding the objective verification of CAPA effectiveness. Additionally, the inspection found that potential consultants were not evaluated based on specified requirements, leading to an unqualified individual serving as a CAPA coach.