FDA 483 - Micro-Technic SAS - September 21, 2023

An FDA inspection of Micro-Technic SAS in Crolles, France, identified a significant issue regarding the establishment and documentation of corrective and preventive action (CAPA) procedures. The firm's procedure for CAPA implementation lacked clear definitions for the use of its action plan workbook, leading to incomplete data entries for cause and efficiency/effectiveness. This indicates a deficiency in the firm's quality system regarding CAPA management.