Warning letter
Curasan AG, Frankfurt Facility: warning letter of Aug 23, 2017
FDA warning letter 534581 · Center for Devices and Radiological Health
Key facts
| Reference number | 534581 |
|---|---|
| Company | Curasan AG, Frankfurt Facility |
| Subject | CGMP/QSR/Medical Devices/Adulterated/Misbranded |
| Issue date | Aug 23, 2017 |
| Posted date | Aug 23, 2017 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803, 803.3, 803.17, 820, 803.50(a) |
| Inspection city | Frankfurt Am Main |
| Inspection start date | May 8, 2017 |
| Letter on fda.gov | fda.gov |
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: