FDA Inspection
Thoratec CorporationThoratec Corporation – FDA Inspection, Oct 13, 2009
Record Details
This FDA Inspection record concerns Thoratec Corporation, with an inspection on October 13, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Thoratec Corporation
- Inspection Date
- October 13, 2009
- Product Type
- Devices
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ID · c59bcba4-5881-44c9-bf63-ff5d070ba357
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 629437
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 820.20(c)Management review participants
- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 812.140(b)(3)Sponsor records of investigator agreements inadequate
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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 |
| April 3, 2017 | VAI | 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 |
Other documents for Thoratec Corporation
- FDA Inspection 1054905 - 2018-05-17
- FDA Inspection 1006393 - 2017-04-03
- FDA Inspection 880973 - 2014-05-30
- FDA Inspection 772501 - 2012-03-16
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