United Therapeutics CorporationMay 2, 2024

FDA 483 - United Therapeutics Corporation - May 02, 2024

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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.

Company: United Therapeutics Corporation
Inspection Date: May 2, 2024
Product Type: Drugs
Office: Office of Regulatory Affairs
People: Annet R. Rajan
Janet A. Rajan (Investigator)
Mindy M. Chou

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ID · c53b028e-fbc1-4e8e-a54d-9923bd725da5