# FDA 483 - Dendreon Pharmaceuticals LLC - April 21, 2022

Source: https://www.keypedia.com/records/483/dendreon-pharmaceuticals-llc/25a116c3-0c75-49e3-a561-9f023a1b9016

> FDA 483 for Dendreon Pharmaceuticals LLC on April 21, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dendreon Pharmaceuticals LLC
- Inspection Date: 2022-04-21
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Dendreon Pharmaceuticals LLC in Union City, GA, a drug manufacturer, was cited for three observations during an FDA inspection. The firm failed to ensure calibration equipment met accuracy limits, leading to out-of-tolerance pipettes used for PROVENGE® product testing. Additionally, investigations into batch failures lacked complete conclusions and follow-up, and product complaints were not closed within established timeframes, with extensions requested and missed.

## 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)

## Related Officers

- [investigator](https://www.keypedia.com/people/brantley-s-collins/c806aac1-3d89-4427-8aeb-6d9db6dfc2f4)
- [Investigator](https://www.keypedia.com/people/burnell-m-henry/dece4407-3597-4a58-8756-5abf9db43bbc)

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