FDA 483 - Catalent Pharma Solutions, LLC - January 30, 2026

An FDA inspection of Catalent Pharma Solutions, LLC in Saint Petersburg, FL, a contract drug manufacturer, revealed significant deficiencies in their quality control unit and procedures for preventing microbiological contamination. The firm failed to control laboratory documentation and retain original raw data, leading to data integrity concerns. Additionally, the facility lacked adequate procedures and testing to prevent objectionable microorganisms in non-sterile drug products, despite environmental monitoring indicating their presence.