FDA Inspection
Dendreon CorporationDendreon Corporation – FDA Inspection, Jan 26, 2011
Record Details
This FDA Inspection record concerns Dendreon Corporation, with an inspection on January 26, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Dendreon Corporation
- Inspection Date
- January 26, 2011
- Product Type
- Biologics
View Company Profile
ID · ba877549-bc4a-4620-9aba-fc6f4231df5c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 730551
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.84(e)Rejecting When Specifications Not Met
- 21 CFR 211.192Investigations of discrepancies, failures
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.