FDA Inspection
Image Diagnostics, Inc.Image Diagnostics, Inc. – FDA Inspection, Aug 6, 2013
Record Details
This FDA Inspection record concerns Image Diagnostics, Inc., with an inspection on August 6, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Image Diagnostics, Inc.
- Inspection Date
- August 6, 2013
- Product Type
- Devices
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ID · bf918393-fb60-46d1-9a39-93cde2647e40
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 843266
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, 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 |
| October 16, 2015 | 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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