Woodstock Sterile Solutions Inc – FDA 483, Jun 9, 2026

Woodstock Sterile Solutions Inc, a human drug manufacturer in Woodstock, IL, was inspected and received a Form 483 with five observations. The inspection revealed significant deficiencies in quality control, including inadequate raw material testing, failures in aseptic processing procedures and environmental monitoring, and a lack of thorough investigations into discrepancies and product complaints. Additionally, the firm's leadership and production staff demonstrated insufficient training in critical areas like smoke study methodology, risk assessment, and cleaning techniques.