FDA Inspection
Dendreon Pharmaceuticals LLCDendreon Pharmaceuticals LLC – FDA Inspection, Jan 19, 2018
Record Details
This FDA Inspection record concerns Dendreon Pharmaceuticals LLC, with an inspection on January 19, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- People
- Arie Menachem (Issuing Officer)
- Mihaly S. Ligmond (FDA Associated Person)
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ID · c7e1845f-cb5b-449a-9b17-557e9b813d17
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1038072
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 600.80(b)Review of Adverse Experiences - promptness
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.122(b)Labeling and packaging improperly approved/released
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 600.80(b)Review of Adverse Experiences - SOPs
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of Dendreon Pharmaceuticals LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 25, 2026 | Not classified | Los Angeles District Office | Human Cellular, Tissue, and Gene Therapies |
| August 10, 2023 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 8, 2019 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 22, 2016 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 15, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Dendreon Pharmaceuticals LLC
- FDA Inspection 1303248 - 2026-03-25
- FDA Inspection 1214688 - 2023-08-10
- FDA Inspection 1109236 - 2019-11-08
- FDA Inspection 961300 - 2016-01-22
- FDA Inspection 848259 - 2012-11-15
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