FDA Inspection
ARB Medical, LLCARB Medical, LLC – FDA Inspection, Jun 15, 2011
Record Details
This FDA Inspection record concerns ARB Medical, LLC, with an inspection on June 15, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ARB Medical, LLC
- Inspection Date
- June 15, 2011
- Product Type
- Devices
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ID · 33f5ca9f-a46f-47ed-9e76-6fe7d6f95fbf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 735896
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
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Other FDA inspections of ARB Medical, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 26, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 11, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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