FDA Inspection
Vivax Medical Corp.Vivax Medical Corp. – FDA Inspection, Aug 11, 2011
Record Details
This FDA Inspection record concerns Vivax Medical Corp., with an inspection on August 11, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Vivax Medical Corp.
- Inspection Date
- August 11, 2011
- Product Type
- Devices
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ID · dd206155-39fb-4064-8b46-49135ad51ad4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 740132
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.80(e)Documentation
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.186QSR
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Other FDA inspections of Vivax Medical Corp.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 17, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 8, 2020 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 14, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 26, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Vivax Medical Corp.
- FDA Inspection 1236380 - 2024-04-17
- FDA Inspection 1115081 - 2020-01-08
- FDA Inspection 1018730 - 2017-07-14
- FDA Inspection 871555 - 2014-03-26
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