Warning letter
Cord for Life, Inc.: warning letter of Mar 29, 2019
FDA warning letter 572770 · Division of Biological Products Operations I
Key facts
| Reference number | 572770 |
|---|---|
| Company | Cord for Life, Inc. |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Mar 29, 2019 |
| Posted date | Apr 3, 2019 |
| Issuing office | Division of Biological Products Operations I |
| Product type | Biologics |
| CFR sections cited | 312, 211.42(c)(10)(iv), 211.67(b), 211.100(a), 211.113(b), 211.160(b), 211.166(a), 1271, 1271.3, 1271.15, 1271.3(c), 1271.3(e) and 4 more |
| Inspection city | Altamonte Springs |
| Inspection ZIP | 32701 |
| Inspection start date | Nov 26, 2018 |
| 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: