Warning letter
Cardiac Assist, Inc: warning letter of May 13, 2014
FDA warning letter 424250 · Philadelphia District Office
Key facts
| Reference number | 424250 |
|---|---|
| Company | Cardiac Assist, Inc |
| Subject | Medical Device Reporting/Misbranded |
| Issue date | May 13, 2014 |
| Posted date | May 20, 2014 |
| Issuing office | Philadelphia District Office |
| Product type | Devices |
| CFR sections cited | 803, 803.50(a)(1) |
| Inspection city | Pittsburgh |
| Inspection ZIP | 15238 |
| Inspection start date | Jan 24, 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: