Warning letter
ALI Pharmaceutical Manufacturing, LLC: warning letter of Mar 30, 2023
FDA warning letter 645781 · Division of Pharmaceutical Quality Operations III
Key facts
| Reference number | 645781 |
|---|---|
| Company | ALI Pharmaceutical Manufacturing, LLC |
| Subject | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Issue date | Mar 30, 2023 |
| Posted date | Oct 31, 2023 |
| Issuing office | Division of Pharmaceutical Quality Operations III |
| Product type | Drugs |
| Inspection city | Omaha |
| Inspection ZIP | 68127 |
| Inspection start date | Sep 26, 2022 |
| 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: