1109236
Dendreon Pharmaceuticals LLC — FEI 3008821247
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 8, 2019
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Seal Beach, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 1219 | 21 CFR 211.67(b)(2) | Cleaning SOPs/schedules |
| 1251 | 21 CFR 211.42(c)(1) | Incoming material area |
| 1388 | 21 CFR 211.101(d) | Component addition checked by 2nd person |
| 1396 | 21 CFR 211.42(c)(2) | Rejected Material Area |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2019 | 21 CFR 211.188(b)(7) | Documentation of Actual Yield and Theoretical Yield |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4576 | 21 CFR 211.192 | No written record of investigation |