FDA Inspection
Image Diagnostics, Inc.Image Diagnostics, Inc. – FDA Inspection, Oct 16, 2015
Record Details
This FDA Inspection record concerns Image Diagnostics, Inc., with an inspection on October 16, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Image Diagnostics, Inc.
- Inspection Date
- October 16, 2015
- Product Type
- Devices
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ID · 35e84358-7808-41a0-9a18-c50ccadb8926
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 946871
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of Image Diagnostics, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 18, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 6, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 10, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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