# FDA 483 - Dendreon Corporation - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/dendreon-corporation/95117ae0-2c28-4510-81c7-242376a18601

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

---

## Details

- Record Type: 483
- Company Name: Dendreon Corporation
- Product Type: biologics
- Office Name: Center for Veterinary Medicine
- Summary: A pre-license inspection of Dendreon Corporation's cell therapy manufacturing facility in Morris Plains, NJ, revealed significant deficiencies. Observations included a lack of data to support concurrent manufacturing, insufficient personnel for aseptic process validation, and inadequate quality control for product identity. The inspection also cited issues with standard operating procedures, including missing timeframes for report closures, lack of regulatory review for change controls, and undefined auditor qualifications, alongside insufficient documentation for formulas and cGMP training.

## Related Officers

- [Director, Team Biologics Staff](https://www.globalkeysolutions.net/people/helen-b-ricalde/455f022e-4d32-453e-acc7-e84a53ce730c)
- [Thomas P. Finn](https://www.globalkeysolutions.net/people/thomas-p-finn/2b697884-9f23-45a1-b056-c52c114f6cb2)
- [Keith Wonnacott](https://www.globalkeysolutions.net/people/keith-wonnacott/5ff3b2ec-56a3-4c75-a7e8-6955e45797d3)
- [Greg Wing](https://www.globalkeysolutions.net/people/greg-wing/37b09ae8-06dd-46a4-acaa-dab6ff8ebc80)
- [Mary P. Padgett](https://www.globalkeysolutions.net/people/mary-p-padgett/e7724bc0-7fda-4038-a86d-4adced14759d)

Company: https://www.globalkeysolutions.net/companies/dendreon-corporation/d8a6072e-7087-47a8-83b8-701727947273

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