FDA Inspection
DynaRad X-Ray, LLCDynaRad X-Ray, LLC – FDA Inspection, Sep 30, 2010
Record Details
This FDA Inspection record concerns DynaRad X-Ray, LLC, with an inspection on September 30, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- DynaRad X-Ray, LLC
- Inspection Date
- September 30, 2010
- Product Type
- Devices
View Company Profile
ID · b46f4d50-59c2-4ab8-9bb8-d3834eb1c589
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 683675
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
2- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 1002.11Failure to submit
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Other FDA inspections of DynaRad X-Ray, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 24, 2012 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| October 8, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 8, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for DynaRad X-Ray, LLC
- FDA Inspection 806938 - 2012-09-24
- FDA Inspection 720727 - 2010-10-08
- FDA Inspection 685196 - 2010-10-08
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