Warning letter
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): warning letter of Jul 30, 2018
FDA warning letter 560736 · Florida District Office
Key facts
| Reference number | 560736 |
|---|---|
| Company | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Jul 30, 2018 |
| Posted date | Jul 30, 2018 |
| Issuing office | Florida District Office |
| Product type | Devices |
| CFR sections cited | 820 |
| Inspection city | Mounds View |
| Inspection ZIP | 55112 |
| Inspection start date | Apr 23, 2018 |
| 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: