Warning letter
Cardiac Designs Inc.: warning letter of Aug 7, 2015
FDA warning letter 476728 · Dallas District Office
Key facts
| Reference number | 476728 |
|---|---|
| Company | Cardiac Designs Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Aug 7, 2015 |
| Posted date | Sep 1, 2015 |
| Issuing office | Dallas District Office |
| Product type | Devices |
| CFR sections cited | 803, 803.3, 803.17, 820, 803.50(a), 803.50(b) |
| Inspection city | Round Rock |
| Inspection ZIP | 78664-6769 |
| Inspection start date | Jun 16, 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: