FDA Inspection
Arobella Medical, LLCArobella Medical, LLC – FDA Inspection, Feb 10, 2012
Record Details
This FDA Inspection record concerns Arobella Medical, LLC, with an inspection on February 10, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Arobella Medical, LLC
- Inspection Date
- February 10, 2012
- Product Type
- Devices
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ID · bcffc8f6-6dcd-4c66-abc0-cfadbec7007f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 767959
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
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Other FDA inspections of Arobella Medical, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 24, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 30, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 13, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 25, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 3, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Arobella Medical, LLC
- FDA Inspection 988502 - 2016-05-24
- FDA Inspection 806110 - 2012-10-30
- FDA Inspection 799193 - 2012-09-13
- FDA Inspection 788325 - 2012-06-25
- FDA Inspection 588209 - 2009-06-03
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