FDA Inspection
Cybernet Medical Corp.Cybernet Medical Corp. – FDA Inspection, Oct 30, 2009
Record Details
This FDA Inspection record concerns Cybernet Medical Corp., with an inspection on October 30, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cybernet Medical Corp.
- Inspection Date
- October 30, 2009
- Product Type
- Devices
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ID · 00fc138d-1054-45df-9789-fe5efd371335
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 629332
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
11- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.198(a)General
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.20Management responsibility
- 21 CFR 820.20(b)(3)Management representative
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.198(b)Rationale documented for no investigation
Showing 10 of 11 citations.
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Other FDA inspections of Cybernet Medical Corp.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 9, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 10, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Cybernet Medical Corp.
- FDA Inspection 814462 - 2013-01-09
- FDA Inspection 707223 - 2011-01-10
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