FDA Inspection
ARB Medical, LLCARB Medical, LLC – FDA Inspection, Jul 26, 2016
Record Details
This FDA Inspection record concerns ARB Medical, LLC, with an inspection on July 26, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ARB Medical, LLC
- Inspection Date
- July 26, 2016
- Product Type
- Devices
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ID · a9de3cb4-39ce-4b68-947e-a8064d4fffa2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 980012
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of ARB Medical, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 11, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 15, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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