Warning letter
Premier Manufacturing Products, LLC: warning letter of Jun 12, 2024
FDA warning letter 678912 · Center for Drug Evaluation and Research | CDER
Key facts
| Reference number | 678912 |
|---|---|
| Company | Premier Manufacturing Products, LLC |
| Subject | Finished Pharmaceuticals/Unapproved New Drug |
| Issue date | Jun 12, 2024 |
| Posted date | Jun 18, 2024 |
| Issuing office | Center for Drug Evaluation and Research | CDER |
| Product type | Drugs |
| Inspection city | Fort Myers |
| Inspection ZIP | 33905-4925 |
| Inspection start date | Jan 22, 2024 |
| Letter on fda.gov | fda.gov |
At a glance
- 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: