# FDA 483 - Dendreon Pharmaceuticals LLC - October 22, 2018

Source: https://www.globalkeysolutions.net/records/483/dendreon-pharmaceuticals-llc/a4c2e9e4-ef11-46c5-89bc-9f9f39b154b3

> FDA 483 for Dendreon Pharmaceuticals LLC on October 22, 2018. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dendreon Pharmaceuticals LLC
- Inspection Date: 2018-10-22
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: The FDA inspected Dendreon Pharmaceuticals Inc. in Union City, GA, and identified significant deficiencies in their quality assurance processes. Observations included failures to review all pertinent records before releasing final products, which led to erroneous potency information and disposition errors. Additionally, the firm lacked proper documentation for corrective actions taken.

## Related Documents

- [483 - 2015-01-09](https://www.globalkeysolutions.net/records/483/dendreon-pharmaceuticals-llc/822eb493-a842-4f0e-af97-b9c9dd995417)
- [483 - 2022-04-21](https://www.globalkeysolutions.net/records/483/dendreon-pharmaceuticals-llc/25a116c3-0c75-49e3-a561-9f023a1b9016)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/burnell-m-henry/dece4407-3597-4a58-8756-5abf9db43bbc)

Company: https://www.globalkeysolutions.net/companies/dendreon-pharmaceuticals-llc/3de4a8e5-8e34-4212-8862-ecd5256c6ffe

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7