FDA 483 - Woodstock Sterile Solutions Inc - March 03, 2022

Woodstock Sterile Solutions, Inc. in Woodstock, IL, a drug product manufacturer, was inspected by the FDA from February 28 to March 3, 2022. The inspection revealed significant issues related to quality control, specifically concerning inadequate investigations into recurring environmental monitoring excursions and a lack of contemporaneous verification for bioburden test results. These findings indicate deficiencies in the firm's quality system and data integrity practices.