Company
United StatesABB Optical Group LLC, Kansas City, MO – FDA Inspections
Inspection records and compliance data for ABB Optical Group LLC in Kansas City, MO. 6 FDA inspections on record, last inspected November 08, 2018.
Company Profile
This profile covers ABB Optical Group LLC based in Kansas City, MO, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 2
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected September 16, 2009. Last inspected November 8, 2018.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Documentation1 inspection
- Info evaluated to determine if event was reportable1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 8, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1075868 |
| October 7, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 899698 |
| April 17, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 776408 |
| April 3, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 777781 |
| November 4, 2009 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 636156 |
| September 16, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 618337 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
ABB Optical Group LLC
FEI Number
2916547
Address
3901 Ne 33rd Ter, Kansas City, MO 64117-2639, United States
Country
United States
ID: d683e8bf-1895-4fe9-8b5d-16d476bab728