Company
United StatesBionix, Llc, Maumee, OH – FDA Inspections
Inspection records and compliance data for Bionix, Llc in Maumee, Ohio. 6 FDA inspections on record, 2 Form 483s, last inspected July 14, 2026.
Company Profile
This profile covers Bionix, Llc based in Maumee, Ohio, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 4
- NAI
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected June 17, 2010. Last inspected July 14, 2026.
Most cited issue areas
- Lack of or inadequate complaint procedures2 inspections
- Lack of or inadequate procedures2 inspections
- Acceptable supplier records, inadequate records1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 14, 2026 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1326218 |
| September 2, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1179655 |
| August 24, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1024053 |
| June 23, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 979145 |
| November 21, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 854680 |
| June 17, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 667265 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Bionix, Llc
FEI Number
1526854
Address
1670 Indian Wood Cir, Maumee, Ohio 43537, United States
Country
United States
ID: 19876df5-bcee-496c-985f-38115caf87ed