# FDA 483 - United Therapeutic Corporation - February 11, 2025

Source: https://www.globalkeysolutions.net/records/483/united-therapeutic-corporation/b7431d0a-f9cd-4859-a3a2-5fb5aa853d51

> FDA 483 for United Therapeutic Corporation on February 11, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: United Therapeutic Corporation
- Inspection Date: 2025-02-11
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: 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.

## Related Documents

- [483 - 2025-02-11](https://www.globalkeysolutions.net/records/483/united-therapeutic-corporation/64504475-b8a9-4292-9345-f172bf218502)

## Related Officers

- [Ofuje D. Daniyan](https://www.globalkeysolutions.net/people/ofuje-d-daniyan/8d7f5014-2a8a-4009-aef6-7e014df97b8b)
- [issuing_officer](https://www.globalkeysolutions.net/people/catherine-o-lamptey/9ddfa564-70b7-4a8b-9209-9d21205ebf60)
- [Investigator](https://www.globalkeysolutions.net/people/pushpa-s-jayasekara/cfd7d22f-b4c2-4002-ae18-b5435815d27d)

Company: https://www.globalkeysolutions.net/companies/united-therapeutic-corporation/fda8d6ce-d684-4496-89b6-5f8b526d83f7

Office: https://www.globalkeysolutions.net/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa