Warning letter
Antaria Pty. Ltd.: warning letter of Mar 22, 2024
FDA warning letter 674495 · Center for Drug Evaluation and Research | CDER
Key facts
| Reference number | 674495 |
|---|---|
| Company | Antaria Pty. Ltd. |
| Subject | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Issue date | Mar 22, 2024 |
| Posted date | Apr 9, 2024 |
| Issuing office | Center for Drug Evaluation and Research | CDER |
| Product type | Drugs |
| Inspection city | Rocklea |
| Inspection start date | Nov 13, 2023 |
| Letter on fda.gov | fda.gov |
At a glance
- 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: