FDA Inspection 953448 — US Stem Cell Clinic, LLC
The FDA completed an inspection of US Stem Cell Clinic, LLC on December 7, 2015 in Sunrise, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 7, 2015
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Sunrise, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 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 |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |