FDA Inspection
Thoratec Switzerland GMBHThoratec Switzerland GMBH – FDA Inspection, May 24, 2018
Record Details
This FDA Inspection record concerns Thoratec Switzerland GMBH, with an inspection on May 24, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · bb107c6f-e409-499f-8d99-df893d1224dd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1055591
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(b)Documentation
- 21 CFR 820.80(e)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Thoratec Switzerland GMBH
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 1, 2018 | Not classified | Office of Inspections and Investigations | |
| April 21, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Thoratec Switzerland GMBH
- FDA Inspection 1107843 - 2018-11-01
- FDA Inspection 724788 - 2011-04-21
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