483
United Therapeutics CorporationUnited Therapeutics Corporation – FDA 483, May 2, 2024
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.
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ID · c53b028e-fbc1-4e8e-a54d-9923bd725da5
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