FDA Inspection
Scion Cardio-Vascular Inc.Scion Cardio-Vascular Inc. – FDA Inspection, Jul 26, 2012
Record Details
This FDA Inspection record concerns Scion Cardio-Vascular Inc., with an inspection on July 26, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Scion Cardio-Vascular Inc.
- Inspection Date
- July 26, 2012
- Product Type
- Devices
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ID · 7218c98a-196d-4ba3-8462-ca7d167dadf6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 794275
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 803.17(b)(4)Info which facilitates timely FDA follow-up
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Other FDA inspections of Scion Cardio-Vascular Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 22, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 30, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Scion Cardio-Vascular Inc.
- FDA Inspection 1082327 - 2019-02-22
- FDA Inspection 936398 - 2015-07-30
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