Warning letter
US Stem Cell Clinic, LLC: warning letter of Aug 24, 2017
FDA warning letter 524470 · Florida District Office
Key facts
| Reference number | 524470 |
|---|---|
| Company | US Stem Cell Clinic, LLC |
| Subject | CGMP Deviations/Current Good Tissue Practice (CGTP) |
| Issue date | Aug 24, 2017 |
| Posted date | Sep 5, 2017 |
| Issuing office | Florida District Office |
| Product type | Biologics |
| CFR sections cited | 211.188(b), 211.182, 312, 211.22(a), 211.28(a), 211.42(c), 211.67(b), 211.80(a), 211.84(a), 211.100(a), 211.113(b), 211.160(b) and 10 more |
| Inspection city | Sunrise |
| Inspection ZIP | 33323 |
| Inspection start date | Apr 10, 2017 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: