FDA 483 - Sterigenics US LLC - March 17, 2017

An FDA inspection of Sterigenics US LLC, a contract sterilizer in Gurnee, IL, revealed significant deficiencies in their quality system. The firm failed to adequately document corrective and preventive action (CAPA) activities and results, including issues with investigation teams, immediate actions, and overdue explanations. Additionally, the firm did not properly establish records for acceptable suppliers, specifically regarding their eCAPA system provider.