FDA Inspection
Image Diagnostics, Inc.Image Diagnostics, Inc. – FDA Inspection, Mar 10, 2011
Record Details
This FDA Inspection record concerns Image Diagnostics, Inc., with an inspection on March 10, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Image Diagnostics, Inc.
- Inspection Date
- March 10, 2011
- Product Type
- Devices
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ID · eef9c023-8401-4a4f-8de5-0abed88a2032
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 713767
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.20(e)Quality System Procedures
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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 |
| October 16, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 6, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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