Warning letter
Kimera Labs, Inc.: warning letter of Sep 1, 2023
FDA warning letter 649343 · Division of Biological Products Operations I
Key facts
| Reference number | 649343 |
|---|---|
| Company | Kimera Labs, Inc. |
| Subject | Investigational Device Exemptions (IDE) |
| Issue date | Sep 1, 2023 |
| Posted date | Sep 19, 2023 |
| Issuing office | Division of Biological Products Operations I |
| Product type | Biologics |
| CFR sections cited | 1271.3(d), 211.176, 211.192, 312, 211.42(c)(10)(v), 211.84(a), 211.100(a), 211.113(b), 211.160(b), 211.166(a), 211.167(a), 312.7(a) and 4 more |
| Inspection city | Miramar |
| Inspection ZIP | 33025 |
| Inspection start date | Jul 11, 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: