Warning letter
Edwards Lifesciences, LLC: warning letter of May 24, 2013
FDA warning letter 394817 · Denver District Office
Key facts
| Reference number | 394817 |
|---|---|
| Company | Edwards Lifesciences, LLC |
| Subject | CGMP/QSR/Medical Device Reporting/Adulterated |
| Issue date | May 24, 2013 |
| Posted date | May 24, 2013 |
| Issuing office | Denver District Office |
| Product type | Devices |
| CFR sections cited | 803.50(a)(2), 820, 807.81(b), 803, 807.81(a)(3)(i) |
| Inspection city | Draper |
| Inspection ZIP | 84020 |
| Inspection start date | Jan 22, 2013 |
| 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: