FDA Inspection
UltraRad CorporationUltraRad Corporation – FDA Inspection, Aug 17, 2017
Record Details
This FDA Inspection record concerns UltraRad Corporation, with an inspection on August 17, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 2dfdc003-af29-41c2-b1d3-803b897fb76e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1021969
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.70(i)Documentation of software validation
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Other FDA inspections of UltraRad Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 18, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 26, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 10, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 5, 2009 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for UltraRad Corporation
- FDA Inspection 1222755 - 2023-08-18
- FDA Inspection 823495 - 2013-03-26
- FDA Inspection 659908 - 2010-05-10
- FDA Inspection 563822 - 2009-03-05
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