# FDA 483 - Prodimed Plastimed Division - February 27, 2020

Source: https://www.globalkeysolutions.net/records/483/prodimed-plastimed-division/7c5a3458-c0af-401b-918d-d7518154cf84

> FDA 483 for Prodimed Plastimed Division on February 27, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Prodimed Plastimed Division
- Inspection Date: 2020-02-27
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Prodimed Plastimed Division in Le Plessis-Bouchard, France, was inspected by the FDA from February 24-27, 2020, resulting in seven observations. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning validation, design control, acceptance activities, corrective and preventive actions, nonconforming product control, production processes, and complaint handling. These issues indicate a broad lack of adequately established procedures across critical manufacturing and quality assurance functions.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/maryam-tabatabaie/b792042d-e296-446d-90a9-d30c8f635506)

Company: https://www.globalkeysolutions.net/companies/prodimed-plastimed-division/5ec63eec-f433-474a-b319-cf1b488904c1

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