Warning letter
St. Jude Medical (CardioMEMS): warning letter of Sep 30, 2015
FDA warning letter 480398 · Atlanta District Office
Key facts
| Reference number | 480398 |
|---|---|
| Company | St. Jude Medical (CardioMEMS) |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Sep 30, 2015 |
| Posted date | Oct 20, 2015 |
| Issuing office | Atlanta District Office |
| Product type | Devices |
| CFR sections cited | 820 |
| Inspection city | Atlanta |
| Inspection ZIP | 30313 |
| Inspection start date | Jun 8, 2015 |
| 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: