1020288
California Stem Cell Treatment — FEI 3009436720
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 26, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Rancho Mirage, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4387 | 21 CFR 211.198(a) | Reporting of adverse drug experience to FDA |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |