FDA Inspection
Cardea Technology, IncCardea Technology, Inc – FDA Inspection, Jun 21, 2010
Record Details
This FDA Inspection record concerns Cardea Technology, Inc, with an inspection on June 21, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cardea Technology, Inc
- Inspection Date
- June 21, 2010
- Product Type
- Devices
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ID · f1a55c7a-15ff-48bb-a57a-eaba3bb04cb9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 667337
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.20(e)Quality System Procedures
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Other FDA inspections of Cardea Technology, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 29, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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