FDA 483 - Prodimed Plastimed Division - February 27, 2020

Prodimed Plastimed Division in Le Plessis-Bouchard, France, was inspected by the FDA from February 24-27, 2020, resulting in seven observations. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning validation, design control, acceptance activities, corrective and preventive actions, nonconforming product control, production processes, and complaint handling. These issues indicate a broad lack of adequately established procedures across critical manufacturing and quality assurance functions.