# FDA 483 - Dendreon Pharmaceuticals LLC - November 08, 2019

Source: https://www.globalkeysolutions.net/records/483/dendreon-pharmaceuticals-llc/00e3c702-5196-4c88-8791-bb84ac9d5006

> FDA 483 for Dendreon Pharmaceuticals LLC on November 08, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dendreon Pharmaceuticals LLC
- Inspection Date: 2019-11-08
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Dendreon Pharmaceuticals, LLC in Seal Beach, CA, a biologic drug manufacturer, revealed significant deficiencies across multiple areas. The firm was cited for issues including inadequate batch production records, untimely investigations into sterility failures, and a lack of proper procedures for aseptic processing and environmental monitoring. Additional concerns involved insufficient data verification, improper material handling and storage, and inadequate temperature control and equipment maintenance.

## Related Documents

- [483 - 2023-08-10](https://www.globalkeysolutions.net/records/483/dendreon-pharmaceuticals-llc/e2b004a3-b6ba-4213-9a5b-442c1772cf9d)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/omotunde-osunsanmi/41c6ef66-1d5c-4940-8b1f-628da20cde34)

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