FDA 483 - Sanofi Winthrop Industrie - July 17, 2018

Sanofi Chimie' in Aramon, France, a drug substance manufacturer, was cited for significant issues during an FDA inspection. Observations included inadequate process validation controls leading to numerous Out-of-Specification results, analytical methods that were not accurate or reproducible, and a failure to timely close out investigations. These issues indicate a severity related to fundamental quality system and manufacturing process control deficiencies.