FDA 483 - Sterlab - June 10, 2022

Sterlab, a medical device manufacturer in Vallauris, France, received a Form FDA-483 with two observations following an inspection. The firm's corrective and preventive action (CAPA) procedures were found to be inadequately established, with issues in investigations, documentation, and implementation. Additionally, Sterlab lacked adequate process control procedures, specifically for quality control testing of sealed pouches and proper identification during processing to prevent mix-ups.