Warning letter
Invitrx Therapeutics, Inc.: warning letter of Nov 9, 2022
FDA warning letter 630712 · Division of Biological Products Operations II
Key facts
| Reference number | 630712 |
|---|---|
| Company | Invitrx Therapeutics, Inc. |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Nov 9, 2022 |
| Posted date | Nov 22, 2022 |
| Issuing office | Division of Biological Products Operations II |
| Product type | Biologics |
| CFR sections cited | 211.198(a), 211.63, 312, 211.84(a), 211.100(a), 211.113(b), 211.160(b), 211.166(a), 211.165(e), 211.188(b), 610.12, 1271 and 8 more |
| Inspection city | Lake Forest |
| Inspection ZIP | 92630 |
| Inspection start date | Mar 1, 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: