FDA 483 - Woodstock Sterile Solutions Inc - September 23, 2025

Woodstock Sterile Solutions Inc. in Woodstock, IL, a drug manufacturer, received a Form 483 with three observations highlighting significant deficiencies. The firm failed to establish adequate production and process controls, lacked proper procedures to prevent microbiological contamination of sterile products, and had deficient calibration procedures for critical manufacturing equipment. These issues collectively indicate a lack of control over product quality, sterility, and process reproducibility.