Warning letter
Invitrx Therapeutics Inc.: warning letter of Mar 16, 2020
FDA warning letter 581182 · Center for Biologics Evaluation and Research (CBER)
Key facts
| Reference number | 581182 |
|---|---|
| Company | Invitrx Therapeutics Inc. |
| Subject | Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
| Issue date | Mar 16, 2020 |
| Posted date | Mar 18, 2020 |
| Issuing office | Center for Biologics Evaluation and Research (CBER) |
| Product type | Biologics |
| CFR sections cited | 1271.15, 211.176, 211.192, 312, 211.42(c)(5), 211.42(c)(10)(iv), 211.67(b), 211.84(a), 211.100(a), 211.113(b), 211.125(f), 211.165(f) and 20 more |
| Inspection city | Lake Forest |
| Inspection ZIP | 92630 |
| Inspection start date | Mar 25, 2019 |
| 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: