Warning letter
Dextrum Laboratories Inc.: warning letter of Dec 7, 2023
FDA warning letter 666442 · Division of Pharmaceutical Quality Operations II
Key facts
| Reference number | 666442 |
|---|---|
| Company | Dextrum Laboratories Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Dec 7, 2023 |
| Posted date | Dec 26, 2023 |
| Issuing office | Division of Pharmaceutical Quality Operations II |
| Product type | Drugs |
| CFR sections cited | 211.34, 211.84(d)(1), 211.84(d)(6), 211.100(a) |
| Inspection city | Miami |
| Inspection ZIP | 33166 |
| Inspection start date | Jul 10, 2023 |
| 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: