FDA 483 - Catalent Pharma Solutions, LLC - July 22, 2025

Catalent Pharma Solutions, LLC in Madison, WI, a drug substance manufacturer, was cited for significant deficiencies across its operations. The inspection revealed inadequate laboratory controls, failures in microbial and cross-contamination risk assessments for open processes, and an ineffective environmental monitoring program. Additionally, the firm lacked a robust cleaning and sanitization program, exhibited poor adherence to standard operating procedures, and had facility and equipment design issues compromising sanitary conditions.