Warning letter
Thoratec Corporation: warning letter of Jan 3, 2012
FDA warning letter 248634 · San Francisco District Office
Key facts
| Reference number | 248634 |
|---|---|
| Company | Thoratec Corporation |
| Subject | CGMP/QSR/Medical Device Reporting/Misbranded |
| Issue date | Jan 3, 2012 |
| Posted date | Jan 3, 2012 |
| Issuing office | San Francisco District Office |
| Product type | Devices |
| CFR sections cited | 803, 803.50(a)(1), 803.50(a)(2), 820, 803.19(e) |
| Inspection city | Pleasanton |
| Inspection ZIP | 94588 |
| Inspection start date | Aug 22, 2011 |
| Letter on fda.gov | web.archive.org |
At a glance
- 1–9 CFR sections cited
- VAI 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: