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

An FDA inspection conducted at Woodstock Sterile Solutions Inc. between September 15 and September 23, 2025, identified several deficiencies in their drug manufacturing operations. These observations indicate areas where the firm's practices do not fully align with regulatory expectations for ensuring product quality and safety.

The primary issues included a failure to establish adequate written procedures for production and process controls. Specifically, the company had not fully developed commercial batch records for a new manufacturing suite and had incomplete sterility assurance activities, such as performance and media qualifications for the facility. Procedures aimed at preventing microbiological contamination of sterile drug products were also not consistently followed. Examples included inadequate smoke studies that did not simulate dynamic conditions with personnel, operators not adhering to proper sterile glove handling techniques, and employees exhibiting movements inconsistent with aseptic practices in controlled environments. Additionally, the inspection found deficiencies in equipment calibration, with critical items like a compounding tank and filling/capping machines not being included in the facility ’s calibration schedule.

Woodstock Sterile Solutions Inc. is expected to promptly address these observations by developing and implementing robust corrective and preventive actions to ensure full compliance with manufacturing quality standards and safeguard the integrity of their drug products.