Warning letter
MKL DIAGNOSTICS AB: warning letter of Jul 29, 2014
FDA warning letter 430843 · Center for Devices and Radiological Health
Key facts
| Reference number | 430843 |
|---|---|
| Company | MKL DIAGNOSTICS AB |
| Subject | CGMP/QSR/Medical Devices/Adulterated/Misbranded |
| Issue date | Jul 29, 2014 |
| Posted date | Jul 29, 2014 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803, 820, 803.17 |
| Inspection city | Sollentuna |
| Inspection start date | Mar 24, 2014 |
| 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: