Warning letter
Niagara Pharmaceuticals Inc.: warning letter of Feb 23, 2007
FDA warning letter UCM076285 · Center for Drug Evaluation and Research
Key facts
| Reference number | UCM076285 |
|---|---|
| Company | Niagara Pharmaceuticals Inc. |
| Subject | CGMP/Drug/Deviations/Adulterated |
| Issue date | Feb 23, 2007 |
| Posted date | Feb 23, 2007 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 211.113(b), 349, 211.100(b), 211.165(a), 211.188(b)(5), 310.502(a)(11), 211.180(e) |
| Country | 3 |
| Inspection city | Dundas |
| Inspection start date | Sep 11, 2006 |
| 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: