Warning letter
Merete Medical GmbH: warning letter of Dec 31, 2018
FDA warning letter 571091 · Center for Devices and Radiological Health
Key facts
| Reference number | 571091 |
|---|---|
| Company | Merete Medical GmbH |
| Subject | CGMP/QSR/Medical Devices/Adulterated/Misbranded |
| Issue date | Dec 31, 2018 |
| Posted date | Feb 12, 2019 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803.17(a), 803, 803.3, 803.17(a)(1), 803.17(a)(3), 803.50(a)(1), 820, 803.50(a) |
| Inspection city | Berlin |
| Inspection start date | Aug 27, 2018 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- VAI 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: