483
United Therapeutic CorporationFDA 483 - United Therapeutic Corporation - February 11, 2025
Record Details
An FDA inspection of United Therapeutic Corporation in Beltsville, MD, identified significant deficiencies in their testing laboratory and warehouse operations. Observations included a lack of appropriate controls over computer systems, allowing unauthorized data manipulation and deletion, and inadequate inventory management practices. The firm failed to properly identify the status of materials and did not consistently use its ERP system for tracking drug products.
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ID · b7431d0a-f9cd-4859-a3a2-5fb5aa853d51