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

Catalent Pharma Solutions, LLC in Saint Petersburg, FL, a contract drug manufacturer, was cited for significant deficiencies in quality control and microbiological contamination prevention. The inspection revealed issues with data integrity, including the use of uncontrolled documents and the discarding of original raw data, alongside a failure to adequately test finished capsule products for microbial contamination and establish proper environmental controls.