# FDA 483 - Fenwal France SAS - April 11, 2014

Source: https://www.globalkeysolutions.net/records/483/fenwal-france-sas/04180dec-c1b2-48a5-86fd-d2ee39b7db5f

> FDA 483 for Fenwal France SAS on April 11, 2014. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fenwal France SAS
- Inspection Date: 2014-04-11
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Fenwal France SAS in La Chatre, France, a medical device contract manufacturer, revealed two significant observations. The firm failed to adequately validate a critical process used for testing containers before and after sterilization. Additionally, the company did not properly control non-conforming products, specifically regarding fill volume deviations in manufactured bags, and failed to evaluate or investigate these issues.

## Related Officers

- [Akbar J. Zaidi](https://www.globalkeysolutions.net/people/akbar-j-zaidi/9cd9ac91-2d4b-4f6f-a975-865342075924)

Company: https://www.globalkeysolutions.net/companies/fenwal-france-sas/dc1d0f0a-e7ec-40e3-bf68-1aea78e944b5

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