# FDA 483 - Vipamat SARL - October 26, 2023

Source: https://www.keypedia.com/records/483/vipamat-sarl/f6e76241-164f-4c56-ae35-bda1ba5623f9

> FDA 483 for Vipamat SARL on October 26, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vipamat SARL
- Inspection Date: 2023-10-26
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Vipamat SARL, a medical device manufacturer in Ploemeur, France, revealed significant deficiencies in their quality system. The firm failed to establish and maintain adequate procedures for medical device reporting, finished device acceptance, design changes, and control over purchased products and services. Additionally, device history records were not properly maintained for their Beach & All Terrain Hippocampe Wheelchair devices.

## Related Officers

- [Joshua J. Silvestri](https://www.keypedia.com/people/joshua-j-silvestri/433e29b3-ce5f-44d2-9984-7a6cb61e1824)

Company: https://www.keypedia.com/companies/vipamat-sarl/5ea4f13c-f7ed-4e8e-8e8b-97745cea571e

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