Warning letter
HeartWare Inc: warning letter of Jun 2, 2014
FDA warning letter 423678 · Florida District Office
Key facts
| Reference number | 423678 |
|---|---|
| Company | HeartWare Inc |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Jun 2, 2014 |
| Posted date | Jul 1, 2014 |
| Issuing office | Florida District Office |
| Product type | Devices |
| CFR sections cited | 820 |
| Inspection city | Miami Lakes |
| Inspection ZIP | 33014 |
| Inspection start date | Jan 13, 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: