# FDA 483 - Dendreon Pharmaceuticals LLC - August 10, 2023

Source: https://www.globalkeysolutions.net/records/483/dendreon-pharmaceuticals-llc/e2b004a3-b6ba-4213-9a5b-442c1772cf9d

> FDA 483 for Dendreon Pharmaceuticals LLC on August 10, 2023. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Dendreon Pharmaceuticals LLC
- Inspection Date: 2023-08-10
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Dendreon Pharmaceuticals LLC in Seal Beach, CA, was inspected from August 2-10, 2023, and received a Form FDA 483 with two observations. The inspection revealed failures in quality control, specifically regarding the rejection of components that did not meet specifications due to sealing issues, and inadequate investigations into particulate matter found in drug products. These issues indicate significant deficiencies in the firm's quality system and its ability to identify root causes and implement effective corrective actions.

## Related Documents

- [483 - 2019-11-08](https://www.globalkeysolutions.net/records/483/dendreon-pharmaceuticals-llc/00e3c702-5196-4c88-8791-bb84ac9d5006)

## Related Officers

- [Consumer Safety Officer at Commissioned Corps of the U.S. Public Health Service](https://www.globalkeysolutions.net/people/latorie-s-jones/086d0897-7d63-4fa8-bdce-f1d17885abd7)
- [investigator](https://www.globalkeysolutions.net/people/susan-m-jackson/2a4e01d1-8761-4d40-b493-69a4163473bb)
- [Investigator](https://www.globalkeysolutions.net/people/burnell-m-henry/dece4407-3597-4a58-8756-5abf9db43bbc)

Company: https://www.globalkeysolutions.net/companies/dendreon-pharmaceuticals-llc/68ccd67e-0a3a-41cb-ae30-e9e10a6eaef5

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6