# FDA 483 - Dendreon Corporation - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/dendreon-corporation/a6252ea3-9cf4-49e9-842b-c604122ddde4

> FDA 483 for Dendreon Corporation on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dendreon Corporation
- Product Type: biologics
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of Dendreon Corporation's cell therapy manufacturing facility in Morris Plains, NJ, identified nine observations during a pre-license inspection for Sipuleucel-T. The observations primarily concern deficiencies in process validation, quality control laboratory procedures, adherence to validated hold times, and inadequate standard operating procedures (SOPs) for exception reporting, investigations, change control, and supplier audits. Additionally, issues with documentation for spreadsheet formulas and cGMP training were noted.

## Related Officers

- [Thomas P. Finn](https://www.globalkeysolutions.net/people/thomas-p-finn/2b697884-9f23-45a1-b056-c52c114f6cb2)
- [Director, Team Biologics Staff](https://www.globalkeysolutions.net/people/helen-b-ricalde/455f022e-4d32-453e-acc7-e84a53ce730c)
- [Keith Wonners](https://www.globalkeysolutions.net/people/keith-wonners/b6a1fcda-bb68-47de-9a22-0d39c33f4035)
- [Mary P. Padgett](https://www.globalkeysolutions.net/people/mary-p-padgett/e7724bc0-7fda-4038-a86d-4adced14759d)
- [Greg Wong](https://www.globalkeysolutions.net/people/greg-wong/ea449b80-7b5e-47ea-8be9-c542fe4cba8f)

Company: https://www.globalkeysolutions.net/companies/dendreon-corporation/f69931ec-1244-4efb-9e92-ea54c27aa2d9

Office: https://www.globalkeysolutions.net/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4