# FDA 483 - Dendreon Pharmaceuticals LLC - October 29, 2025

Source: https://www.keypedia.com/records/483/dendreon-pharmaceuticals-llc/02475899-e839-4b59-9576-e51710d93dae

> FDA 483 for Dendreon Pharmaceuticals LLC on October 29, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dendreon Pharmaceuticals LLC
- Inspection Date: 2025-10-29
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Dendreon Pharmaceuticals LLC in Union City, GA, revealed significant deficiencies in laboratory record-keeping and manufacturing process controls. The firm failed to maintain complete data for invalid test results for its PROVENGE® drug product and continued to use disinfectants despite failed efficacy studies without proper investigation. These issues indicate a lack of robust quality control and data integrity.

## Related Documents

- [483 - 2015-01-09](https://www.keypedia.com/records/483/dendreon-pharmaceuticals-llc/822eb493-a842-4f0e-af97-b9c9dd995417)
- [483 - 2018-10-22](https://www.keypedia.com/records/483/dendreon-pharmaceuticals-llc/a4c2e9e4-ef11-46c5-89bc-9f9f39b154b3)
- [483 - 2022-04-21](https://www.keypedia.com/records/483/dendreon-pharmaceuticals-llc/25a116c3-0c75-49e3-a561-9f023a1b9016)

## Related Officers

- [Brentley S. Pittman](https://www.keypedia.com/people/brentley-s-pittman/d583b2b0-e12f-4b7c-a21b-6a0d75cac255)

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

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