483
United Therapeutics CorporationFDA 483 - United Therapeutics Corporation - May 02, 2024
Discuss this record with AI
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.
Record Details
An FDA inspection of United Therapeutics Corporation in Silver Spring, MD, revealed significant deficiencies in sterile drug product manufacturing. Observations included inadequate airflow pattern evaluations and environmental monitoring for sterile filling lines, as well as failures in thoroughly reviewing out-of-specification results. Additionally, the firm accepted supplier analyses for components without proper validation.
Open in Dashboard
ID · c53b028e-fbc1-4e8e-a54d-9923bd725da5