FDA Inspection
UltraRad CorporationUltraRad Corporation – FDA Inspection, Mar 26, 2013
Record Details
This FDA Inspection record concerns UltraRad Corporation, with an inspection on March 26, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- UltraRad Corporation
- Inspection Date
- March 26, 2013
- Product Type
- Devices
View Company Profile
ID · 68dabaff-3755-4e11-9811-65f5c56f2aae
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 823495
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.25(b)Training records
- 21 CFR 820.198(b)Rationale documented for no investigation
- 21 CFR 820.40(b)Document change records, maintained.
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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 |
| August 17, 2017 | 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 1021969 - 2017-08-17
- FDA Inspection 659908 - 2010-05-10
- FDA Inspection 563822 - 2009-03-05
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