# FDA 483 - Maquet SAS - February 01, 2018

Source: https://www.keypedia.com/records/483/maquet-sas/79dd44c1-6754-4d84-aacd-12a711699108

> FDA 483 for Maquet SAS on February 01, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Maquet SAS
- Inspection Date: 2018-02-01
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Maquet SAS, a medical device manufacturer in Orleans, France, revealed significant deficiencies in their quality management system. Observations included inadequate procedures for corrective and preventive actions, insufficient controls for incoming product acceptance, and a lack of proper validation for a final product testing process. These issues indicate a need for comprehensive improvements in their quality processes.

## Related Documents

- [483 - 2025-01-16](https://www.keypedia.com/records/483/maquet-sas/6a029879-bc9b-4eb0-b0c0-9a76009a6314)

## Related Officers

- [Medical Device Senior Operations Officer at FDA](https://www.keypedia.com/people/thomas-a-peter/48a36892-cc03-42bb-8960-978d18f2147a)

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

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