Micro-Technic SASSeptember 21, 2023

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

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Record Details

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.

Company: Micro-Technic SAS
Inspection Date: September 21, 2023
Product Type: Other
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Tyler R. Courtney (investigator)

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ID · 9c5f9b57-ad60-4203-a892-77725919a1e0