Warning letter
Utah Cord Bank LLC: warning letter of May 11, 2021
FDA warning letter 614021 · Office Biological Products Operations – Division 2
Key facts
| Reference number | 614021 |
|---|---|
| Company | Utah Cord Bank LLC |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | May 11, 2021 |
| Posted date | Jun 1, 2021 |
| Issuing office | Office Biological Products Operations – Division 2 |
| Product type | Biologics |
| CFR sections cited | 1271.180(a), 1271.190(d), 1271.195(c), 1271.195(d), 1271.200(b), 1271.200(e), 1271.260(e), 1271.210(d), 1271.270(a), 1271.230(a), 1271.320(b), 1271 and 2 more |
| Inspection city | Sandy |
| Inspection ZIP | 84070 |
| Inspection start date | Feb 1, 2021 |
| 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: