FDA Inspection
Dendreon Pharmaceuticals LLCDendreon Pharmaceuticals LLC – FDA Inspection, Nov 8, 2019
Record Details
This FDA Inspection record concerns Dendreon Pharmaceuticals LLC, with an inspection on November 8, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Dendreon Pharmaceuticals LLC
- Inspection Date
- November 8, 2019
- Product Type
- Biologics
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ID · 54955f40-a4c2-4bc9-981a-fc18dba66ec3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1109236
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
10- 21 CFR 211.101(d)Component addition checked by 2nd person
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.67(b)(2)Cleaning SOPs/schedules
- 21 CFR 211.42(c)(2)Rejected Material Area
- 21 CFR 211.42(c)(1)Incoming material area
- 21 CFR 211.188(b)(7)Documentation of Actual Yield and Theoretical Yield
- 21 CFR 211.100(a)Approval and review of procedures
- 21 CFR 211.192No written record of investigation
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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 |
| January 19, 2018 | 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 1038072 - 2018-01-19
- FDA Inspection 961300 - 2016-01-22
- FDA Inspection 848259 - 2012-11-15
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