FDA Inspection
ABB Optical Group LLCABB Optical Group LLC – FDA Inspection, Nov 4, 2009
Record Details
This FDA Inspection record concerns ABB Optical Group LLC, with an inspection on November 4, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ABB Optical Group LLC
- Inspection Date
- November 4, 2009
- Product Type
- Devices
View Company Profile
ID · 52f1ac41-e97c-4401-8ae8-2d270a394556
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 636156
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.25(b)Training records
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.198(b)Rationale documented for no investigation
- 21 CFR 820.180(b)Retention period
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
- 21 CFR 803.17(b)(1)Info evaluated to determine if event was reportable
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 |
| April 3, 2012 | VAI | Center for Devices and Radiological Health | Compliance: 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 777781 - 2012-04-03
- FDA Inspection 618337 - 2009-09-16
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.