FDA 483 - Woodstock Sterile Solutions Inc - June 25, 2019

An FDA inspection of Catalent Pharma Solutions, LLC in Woodstock, IL, a drug product manufacturer, revealed several significant deficiencies. These included inadequate environmental monitoring, failure to follow standard operating procedures, an insufficient visual inspection process, poorly maintained utilities and equipment, and an inadequate production batch record for yield discrepancies. The findings indicate a need for improved control over critical manufacturing and quality processes.