# FDA 483 - United Therapeutics Corporation - May 02, 2024

Source: https://www.keypedia.com/records/483/united-therapeutics-corporation/c53b028e-fbc1-4e8e-a54d-9923bd725da5

> FDA 483 for United Therapeutics Corporation on May 02, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: United Therapeutics Corporation
- Inspection Date: 2024-05-02
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: 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.

## Related Officers

- [Mindy M. Chou](https://www.keypedia.com/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)
- [Annet R. Rajan](https://www.keypedia.com/people/annet-r-rajan/81b5a458-094f-48a5-839d-5c47b1a7c259)
- [Investigator](https://www.keypedia.com/people/janet-a-rajan/95741927-9a4d-422b-bd51-01783d962cbe)

Company: https://www.keypedia.com/companies/united-therapeutics-corporation/c84eda64-b69f-4f0b-b5b2-67bbd708285b

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64