# FDA 483 - Prince Medical S.A.S. - December 08, 2022

Source: https://www.keypedia.com/records/483/prince-medical-sas/59b5f880-ead2-446d-b5de-9206b69f5f83

> FDA 483 for Prince Medical S.A.S. on December 08, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Prince Medical S.A.S.
- Inspection Date: 2022-12-08
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of Prince Medical S.A.S., a medical device manufacturer in Ercuis, France, revealed significant deficiencies in their quality system. Observations included inadequate complaint handling procedures, a repeat finding from a previous inspection, and failures in documenting design verification results. Additionally, the firm lacked established requirements for contractors and consultants, and procedures for corrective and preventive actions were not properly implemented.

## Related Officers

- [Colin E. Tack](https://www.keypedia.com/people/colin-e-tack/5bdbf977-d4ac-48fe-81cc-ada89379ed0d)

Company: https://www.keypedia.com/companies/prince-medical-sas/9ec84cba-5561-42c5-ac41-54389d21b4f2

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4