Company
United StatesBion Enterprises Ltd., Des Plaines, IL – FDA Inspections
Inspection records and compliance data for Bion Enterprises Ltd. in Des Plaines, Illinois. 4 FDA inspections on record, 1 Form 483, last inspected November 18, 2016.
Company Profile
This profile covers Bion Enterprises Ltd. based in Des Plaines, Illinois, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected March 2, 2009. Last inspected November 18, 2016.
Most cited issue areas
- Change records, content1 inspection
- Design history file1 inspection
- Documentation1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 18, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 993559 |
| April 18, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 777732 |
| December 3, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 633746 |
| March 2, 2009 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 566149 |
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
Bion Enterprises Ltd.
FEI Number
1419968
Address
455 State St Ste 100, Des Plaines, Illinois 60016, United States
Country
United States
ID: 98acb389-8381-4feb-ae7d-e0e4810354f3