Warning letter
Denison Pharmaceuticals, LLC: warning letter of Jul 26, 2023
FDA warning letter 654226 · Division of Pharmaceutical Quality Operations I
Key facts
| Reference number | 654226 |
|---|---|
| Company | Denison Pharmaceuticals, LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Jul 26, 2023 |
| Posted date | Aug 15, 2023 |
| Issuing office | Division of Pharmaceutical Quality Operations I |
| Product type | Drugs |
| CFR sections cited | 211.84(d)(1), 211.34, 211.165(e), 211.192 |
| Inspection city | Lincoln |
| Inspection ZIP | 02865 |
| Inspection start date | Jan 5, 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: