Warning letter
Applied Therapeutics, Inc.: warning letter of Dec 3, 2024
FDA warning letter 696833 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 696833 |
|---|---|
| Company | Applied Therapeutics, Inc. |
| Subject | Sponsor |
| Issue date | Dec 3, 2024 |
| Posted date | Dec 3, 2024 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 314.50(d)(5)(iv), 312, 312.58 |
| Inspection city | New York |
| Inspection ZIP | 10017 |
| Inspection start date | Apr 29, 2024 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 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: