483
Catalent Pharma Solutions, LLCCatalent Pharma Solutions, LLC – FDA 483, Jan 30, 2026
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.
View Company Profile
ID · 93c4cc9c-fd83-4c26-9023-0b4c62c93c56
Other documents for Catalent Pharma Solutions, LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.