FDA Inspection
Vivax Medical Corp.Vivax Medical Corp. – FDA Inspection, Mar 26, 2014
Record Details
This FDA Inspection record concerns Vivax Medical Corp., with an inspection on March 26, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Vivax Medical Corp.
- Inspection Date
- March 26, 2014
- Product Type
- Devices
View Company Profile
ID · cfdc0c20-2e77-4a14-8aa0-09d8eb9bc1d2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 871555
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
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 |
| August 11, 2011 | VAI | Center for Devices and Radiological Health | Compliance: 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 740132 - 2011-08-11
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