Warning letter
Noven Pharmaceuticals, Inc.: warning letter of Jan 4, 2008
FDA warning letter UCM1048450 · Florida District Office
Key facts
| Reference number | UCM1048450 |
|---|---|
| Company | Noven Pharmaceuticals, Inc. |
| Subject | CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated |
| Issue date | Jan 4, 2008 |
| Posted date | Jan 4, 2008 |
| Issuing office | Florida District Office |
| Product type | Drugs |
| CFR sections cited | 211, 211.192, 211.198, 211.160(b), 211.1, 211.137(a), 211.180(e) |
| Country | 3 |
| Inspection city | Miami |
| Inspection ZIP | 33186-6109 |
| Inspection start date | Jun 11, 2007 |
| Letter on fda.gov | web.archive.org |
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: