Warning letter
Instrumed Gmbh: warning letter of Mar 28, 2014
FDA warning letter 415984 · Center for Devices and Radiological Health
Key facts
| Reference number | 415984 |
|---|---|
| Company | Instrumed Gmbh |
| Subject | Medical Device Reporting/Adulterated/Misbranding |
| Issue date | Mar 28, 2014 |
| Posted date | Mar 28, 2014 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 820, 803.56, 803.17, 803.17(b)(1), 803.17(a)(3), 803, 820.40 |
| Inspection city | Tuttlingen |
| Inspection start date | Jul 29, 2013 |
| 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: