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

Source: https://www.globalkeysolutions.net/records/483/micro-technic-sas/9c5f9b57-ad60-4203-a892-77725919a1e0

> FDA 483 for Micro-Technic SAS on September 21, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Micro-Technic SAS
- Inspection Date: 2023-09-21
- Product Type: other
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/tyler-r-courtney/08ea96c4-cd5a-4793-b7e4-fb2b9ee2b9ef)

Company: https://www.globalkeysolutions.net/companies/micro-technic-sas/8cae80fc-9179-499c-83eb-5b7ae42fbc63

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd