FDA Inspection 1013848 — US Stem Cell Clinic, LLC
The FDA completed an inspection of US Stem Cell Clinic, LLC on May 11, 2017 in Sunrise, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 11, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Sunrise, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 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 |