FDA 483 - Fenwal France SAS - April 11, 2014

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.