Warning letter
Sanochemia Pharmazeutika AG: warning letter of Nov 19, 2006
FDA warning letter UCM076175 · Center for Biologics Evaluation and Research
Key facts
| Reference number | UCM076175 |
|---|---|
| Company | Sanochemia Pharmazeutika AG |
| Subject | Quality System Regulation |
| Issue date | Nov 19, 2006 |
| Posted date | Nov 19, 2006 |
| Issuing office | Center for Biologics Evaluation and Research |
| Product type | Biologics |
| CFR sections cited | 820.5, 820, 600.12, 600.14, 803 |
| Country | 3 |
| Inspection city | Neufeld an der Leitha |
| Inspection start date | May 9, 2006 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- 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: