Fenwal France SASApril 11, 2014

FDA 483 - Fenwal France SAS - April 11, 2014

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Record Details

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.

Company: Fenwal France SAS
Inspection Date: April 11, 2014
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Akbar J. Zaidi

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ID · 04180dec-c1b2-48a5-86fd-d2ee39b7db5f