Catalent Pharma Solutions, LLCJanuary 30, 2026

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

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Record Details

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.

Company: Catalent Pharma Solutions, LLC
Inspection Date: January 30, 2026
Product Type: Drugs
Office: Florida District Office
People: Danny T. Fernandez
Tammy T. Brown (investigator)
Damaris Y. Hernandez
Nicole E. Knowlton (Investigator )

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ID · 93c4cc9c-fd83-4c26-9023-0b4c62c93c56