Warning letter
Andersen Pharmaceuticals: warning letter of Mar 4, 2004
FDA warning letter UCM146240 · New York District Office
Key facts
| Reference number | UCM146240 |
|---|---|
| Company | Andersen Pharmaceuticals |
| Subject | Unapproved New Drug/Misbranded |
| Issue date | Mar 4, 2004 |
| Posted date | Mar 4, 2004 |
| Issuing office | New York District Office |
| Product type | Devices |
| CFR sections cited | 201.66, 207, 211.103, 211.192, 347, 211.100(b), 211.188(a), 211.188(b), 347.10(b), 347.12(b), 347.52(c)(1), 347.50(a) and 2 more |
| Country | 3 |
| Inspection city | Norwich |
| Inspection ZIP | 13815-0848 |
| Inspection start date | Sep 24, 2003 |
| Letter on fda.gov | web.archive.org |
At a glance
- 10–99 CFR sections cited
- VAI 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: