FDA Inspection
ABB Optical Group LLCABB Optical Group LLC – FDA Inspection, Apr 3, 2012
Record Details
This FDA Inspection record concerns ABB Optical Group LLC, with an inspection on April 3, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ABB Optical Group LLC
- Inspection Date
- April 3, 2012
- Product Type
- Devices
View Company Profile
ID · d21fe811-b939-4bee-ae8f-541b2a1c478d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 777781
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.22Quality audits - auditor independence
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ABB Optical Group LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| November 8, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 7, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 17, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 4, 2009 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 16, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for ABB Optical Group LLC
- FDA Inspection 1075868 - 2018-11-08
- FDA Inspection 899698 - 2014-10-07
- FDA Inspection 776408 - 2012-04-17
- FDA Inspection 636156 - 2009-11-04
- FDA Inspection 618337 - 2009-09-16
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