Warning letter
BioStem Life Sciences: warning letter of Jan 17, 2025
FDA warning letter 673788 · Center for Biologics Evaluation and Research (CBER)
Key facts
| Reference number | 673788 |
|---|---|
| Company | BioStem Life Sciences |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Jan 17, 2025 |
| Posted date | Feb 4, 2025 |
| Issuing office | Center for Biologics Evaluation and Research (CBER) |
| Product type | Biologics |
| CFR sections cited | 211.42(c)(10)(iv), 211.42(c)(10)(v), 211.100(a), 211.113(b), 211.160(b), 211.166(a), 1271, 1271.1, 1271.15, 1271.20, 1271.3(c), 1271.3(f)(1) and 3 more |
| Inspection city | Pompano Beach |
| Inspection ZIP | 33064 |
| Inspection start date | Sep 11, 2023 |
| 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: