Company
United StatesControl Bionics, Milford, OH – FDA Inspections
Inspection records and compliance data for Control Bionics in Milford, Ohio. 5 FDA inspections on record, last inspected September 18, 2026.
Company Profile
This profile covers Control Bionics based in Milford, Ohio, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected July 1, 2010. Last inspected September 18, 2026.
Most cited issue areas
- Criteria for the evaluation and selection of suppliers not established1 inspection
- QMS software not validated prior to use or changes1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 18, 2026 | VAI | · Compliance: Devices | 1336296 |
| June 6, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1207781 |
| February 27, 2020 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1122520 |
| September 8, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 985365 |
| July 1, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 669901 |
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
Control Bionics
FEI Number
3006789226
Address
745 Center St Ste 303, Milford, Ohio 45150, United States
Country
United States
ID: 966b05df-71c0-4640-a42c-d2d6c7fb6389