FDA 483 - Medistri SA - May 09, 2024

Medistri SA, a contract sterilizer, was cited with two observations during an FDA inspection in Domdidier, Switzerland. The firm's procedures for corrective and preventive actions (CAPA) were found to be inadequately established, lacking complete documentation for effectiveness verification and risk assessments. Additionally, the company's complaint handling process was deemed insufficient, failing to ensure proper identification and uniform processing of customer complaints.