Warning letter
Biotronik SE & Co. KG: warning letter of Sep 1, 2016
FDA warning letter 500732 · Center for Devices and Radiological Health
Key facts
| Reference number | 500732 |
|---|---|
| Company | Biotronik SE & Co. KG |
| Subject | CGMP/QSR/Medical Devices/Adulterated/Misbranded |
| Issue date | Sep 1, 2016 |
| Posted date | Jan 30, 2017 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803, 803.17, 803.50(a)(2), 820 |
| Inspection city | Berlin |
| Inspection start date | Mar 7, 2016 |
| 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: