# FDA 483 - Dendreon Pharmaceuticals LLC - March 25, 2026

Source: https://www.keypedia.com/records/483/dendreon-pharmaceuticals-llc/942564da-2f47-4359-af4a-599a4ffd94b6

> FDA 483 for Dendreon Pharmaceuticals LLC on March 25, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dendreon Pharmaceuticals LLC
- Inspection Date: 2026-03-25
- Product Type: biologics
- Office Name: Los Angeles District Office
- Summary: Dendreon Pharmaceuticals LLC in Seal Beach, CA, a biological drug manufacturer, was cited for numerous significant deficiencies during an FDA inspection. The observations highlight critical failures in quality control, including inadequate investigations into product discrepancies, insufficient aseptic processing controls, lack of proper validation for manufacturing changes, and poor record-keeping practices for sterile drug product manufacturing. These issues indicate a systemic breakdown in ensuring the safety, quality, and purity of their Sipuleucel-T drug product.

## Related Documents

- [EIR - 2018-01-19](https://www.keypedia.com/records/eir/dendreon-pharmaceuticals-llc/97f7cc77-728b-489d-a94b-1f030700d52e)
- [483 - 2019-11-08](https://www.keypedia.com/records/483/dendreon-pharmaceuticals-llc/00e3c702-5196-4c88-8791-bb84ac9d5006)
- [483 - 2023-08-10](https://www.keypedia.com/records/483/dendreon-pharmaceuticals-llc/e2b004a3-b6ba-4213-9a5b-442c1772cf9d)

## Related Officers

- [Consumer Safety Officer Drug Specialist](https://www.keypedia.com/people/sony-mathews/4d42379f-1245-494c-8c19-6cefa4e560a5)
- [FDA_PERSONNEL](https://www.keypedia.com/people/lizaida-perez/686fbdca-bfd7-4a73-990a-d8a97e6b88b7)
- [Esther A. Ofori](https://www.keypedia.com/people/esther-a-ofori/98108fae-1e09-4849-bceb-18e69dff7ba4)
- [Emily B. Camire](https://www.keypedia.com/people/emily-b-camire/dff5f4c6-bcbe-4ef1-ac0b-1b2701b311ef)
- [Benny Mathews](https://www.keypedia.com/people/benny-mathews/a0c2f18f-b528-492e-8763-17943a4cbd11)

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

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b