Warning letter
Whitney Labs: warning letter of Sep 2, 2008
FDA warning letter UCM1048154 · Florida District Office
Key facts
| Reference number | UCM1048154 |
|---|---|
| Company | Whitney Labs |
| Subject | CGMP for Finished Pharmaceuticals/Deviations/Adulterated |
| Issue date | Sep 2, 2008 |
| Posted date | Sep 2, 2008 |
| Issuing office | Florida District Office |
| Product type | Drugs |
| CFR sections cited | 211.80(a), 211.22, 211.137, 211.192, 211.25(a), 211.100(a), 211.100(b), 211.166(a), 211.170(b), 211.180(e), 211.198(a) |
| Country | 3 |
| Inspection city | Ormond Beach |
| Inspection ZIP | 32174-1921 |
| Inspection start date | Mar 12, 2008 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 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: