Warning letter
Azurity Pharmaceuticals, Inc.: warning letter of Sep 20, 2024
FDA warning letter 656489 · Center for Drug Evaluation and Research (CDER)
Key facts
| Reference number | 656489 |
|---|---|
| Company | Azurity Pharmaceuticals, Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug |
| Issue date | Sep 20, 2024 |
| Posted date | Sep 24, 2024 |
| Issuing office | Center for Drug Evaluation and Research (CDER) |
| Product type | Drugs |
| CFR sections cited | 211.166(a), 201.128, 211.34, 211.192 |
| Inspection city | Wilmington |
| Inspection ZIP | 01887-3414 |
| Inspection start date | Feb 2, 2023 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- 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: