# FDA 483 - Dendreon Corporation - November 02, 2018

Source: https://www.globalkeysolutions.net/records/483/dendreon-corporation/c069757e-3fbd-4914-9602-d4ac0aa73138

> FDA 483 for Dendreon Corporation on November 02, 2018. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dendreon Corporation
- Inspection Date: 2018-11-02
- Product Type: biologics
- Office Name: Milk Safety Program - Branch 2
- Summary: Dendreon Pharmaceuticals, LLC in Seattle, WA, was cited for significant deficiencies in their analytical testing laboratory during an FDA inspection. The firm failed to maintain consistency between their internal documents and the Biologics License Application, exhibited poor control over computer systems leading to data integrity concerns, and inadequately investigated out-of-specification results. Additionally, the inspection revealed a lack of proper training re-qualification for analysts.

## Related Officers

- [Anita Narula, Ph.D., CSO - Biotechnology](https://www.globalkeysolutions.net/people/anita-narula-phd-cso-biotechnology/58c5451d-046e-42a0-87f1-ff9b277ef60e)
- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/kenneth-o-gee/d61312c0-1422-4487-a5d6-ec6e76d242ee)

Company: https://www.globalkeysolutions.net/companies/dendreon-corporation/378cf699-7e31-4edf-b0f9-5ad6928ec74d

Office: https://www.globalkeysolutions.net/offices/milk-safety-program-branch-2/ec1172a8-6b3b-4251-ad1c-6c6b6868ba6f