FDA Inspection
Thoratec CorporationThoratec Corporation – FDA Inspection, Apr 3, 2017
Record Details
This FDA Inspection record concerns Thoratec Corporation, with an inspection on April 3, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f520c1d5-cd65-4402-8046-e381b78b6dfb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1006393
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.40Sponsors' general responsibilities
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Other FDA inspections of Thoratec Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 17, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| May 30, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 16, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 13, 2009 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Thoratec Corporation
- FDA Inspection 1054905 - 2018-05-17
- FDA Inspection 880973 - 2014-05-30
- FDA Inspection 772501 - 2012-03-16
- FDA Inspection 629437 - 2009-10-13
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