# FDA 483 - Novatech S.A. - September 05, 2019

Source: https://www.keypedia.com/records/483/novatech-sa/d8be82a5-42cd-4196-b4ce-b01425cacf22

> FDA 483 for Novatech S.A. on September 05, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novatech S.A.
- Inspection Date: 2019-09-05
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Novatech S.A., a medical device manufacturer in La Ciotat Cedex, France, was inspected by the FDA and received nine observations related to significant deficiencies in its quality system. Key issues include the lack of a complete design history file for a Class II device, inadequate procedures for non-conforming product, CAPA, complaint handling, risk analysis, process validation, supplier control, quality audits, and management review. The findings indicate a broad failure to establish and follow adequate quality system procedures.

## Related Officers

- [Investigator ](https://www.keypedia.com/people/benjamin-j-dastoli/688c2ad7-f7ac-47eb-8ca2-4efcd221f636)

Company: https://www.keypedia.com/companies/novatech-sa/5df959a3-82be-476e-93bd-b26998a35cca

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