Warning letter
Row1 Inc. dba Regenative Labs: warning letter of Jun 21, 2023
FDA warning letter 638823 · Division of Biological Products Operations I
Key facts
| Reference number | 638823 |
|---|---|
| Company | Row1 Inc. dba Regenative Labs |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Jun 21, 2023 |
| Posted date | Jul 11, 2023 |
| Issuing office | Division of Biological Products Operations I |
| Product type | Biologics |
| CFR sections cited | 211.100(a), 211.113(b), 211.166(a), 1271, 1271.15, 1271.3(c), 1271.3(f)(1), 1271.10(a), 1271.10(a)(1), 1271.10(a)(2), 312, 1271.3(d) |
| Inspection city | Pensacola |
| Inspection ZIP | 32502 |
| Inspection start date | Mar 21, 2022 |
| 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: