# FDA 483 - Maquet SAS - January 16, 2025

Source: https://www.keypedia.com/records/483/maquet-sas/6a029879-bc9b-4eb0-b0c0-9a76009a6314

> FDA 483 for Maquet SAS on January 16, 2025. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Maquet SAS
- Inspection Date: 2025-01-16
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: Maquet SAS, a medical device manufacturer in Orleans cedex 2, France, was inspected by the FDA from January 13-16, 2025. The inspection revealed deficiencies in the firm's procedures for controlling nonconforming products and for establishing adequate device history records. These issues indicate a lack of robust quality system controls.

## Related Documents

- [483 - 2018-02-01](https://www.keypedia.com/records/483/maquet-sas/79dd44c1-6754-4d84-aacd-12a711699108)

## Related Officers

- [investigator](https://www.keypedia.com/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.keypedia.com/companies/maquet-sas/7e2d533e-d7fc-4715-b60c-928657757140

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8