Warning letter
Similasan AG: warning letter of Aug 16, 2005
FDA warning letter UCM075520 · Center for Drug Evaluation and Research
Key facts
| Reference number | UCM075520 |
|---|---|
| Company | Similasan AG |
| Subject | Cuurent Good Manufacturing Practice/Adulterated/Misbranded |
| Issue date | Aug 16, 2005 |
| Posted date | Aug 16, 2005 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Devices |
| CFR sections cited | 211.192, 201.5, 211.46, 211.63, 211.67, 211.113, 211.122, 211.160, 211.188 |
| Country | 3 |
| Inspection city | Jonen |
| Inspection start date | Apr 4, 2005 |
| 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: