# FDA 483 - INTECH Medical SAS - April 08, 2024

Source: https://www.keypedia.com/records/483/intech-medical-sas/2b0e2517-3070-4382-8154-e6f740d54eb1

> FDA 483 for INTECH Medical SAS on April 08, 2024. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: INTECH Medical SAS
- Inspection Date: 2024-04-08
- Product Type: device
- Office Name: Foreign - CBER (Bioresearch Monitoring)
- Summary: An FDA inspection of INTECH MEDICAL SAS in Rang Du Fliers, France, identified significant deficiencies in their quality management system. The firm failed to adequately establish procedures for controlling non-conforming product, managing corrective and preventive actions, and ensuring proper medical device reporting. These findings indicate a need for comprehensive improvements across several critical quality system areas.

## Related Officers

- [investigator](https://www.keypedia.com/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)

Company: https://www.keypedia.com/companies/intech-medical-sas/4d1272c9-9430-4551-9257-55977ec1594e

Office: https://www.keypedia.com/offices/foreign-cber-bioresearch-monitoring/f1660531-9111-4f36-bf5d-b28bf0f3b54e