483
Fenwal France SASFenwal France SAS – FDA 483, Apr 11, 2014
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.
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ID · 04180dec-c1b2-48a5-86fd-d2ee39b7db5f
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