Warning letter
Stemell Inc: warning letter of Aug 28, 2019
FDA warning letter 579013 · Office of Biological Products Operations - Division II
Key facts
| Reference number | 579013 |
|---|---|
| Company | Stemell Inc |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Aug 28, 2019 |
| Posted date | Sep 3, 2019 |
| Issuing office | Office of Biological Products Operations - Division II |
| Product type | Biologics |
| CFR sections cited | 312, 211.22(a), 211.42(c)(10), 211.68(a), 211.80(a), 211.100(a), 211.113(b), 211.160(b), 211.166(a), 211.198(a), 1271, 1271.3 and 8 more |
| Inspection city | San Juan Capistrano |
| Inspection ZIP | 92675 |
| Inspection start date | Mar 4, 2019 |
| 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: