Company
United StatesOhio Medical Corporation, Gurnee, IL – FDA Inspections
Inspection records and compliance data for Ohio Medical Corporation in Gurnee, Illinois. 6 FDA inspections on record (2 OAI), 1 warning letter, last inspected November 26, 2024.
Company Profile
This profile covers Ohio Medical Corporation based in Gurnee, Illinois, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 2
- VAI
- 3
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 1
First inspected May 19, 2009. Last inspected November 26, 2024.
Most cited issue areas
- Documentation4 inspections
- Lack of or inadequate procedures4 inspections
- Individual Report of Malfunction3 inspections
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 26, 2024 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1250929 |
| December 29, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 920811 |
| December 21, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 814785 |
| June 9, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 730544 |
| June 14, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 668559 |
| May 19, 2009 | OAI | Medical Devices & Rad Health · Compliance: Devices | 583433 |
FDA documents
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Ohio Medical Corporation
FEI Number
1419185
Address
1111 Lakeside Dr, Gurnee, Illinois 60031, United States
Country
United States
ID: 0fa560b7-4665-48a9-8cbc-9026bd7a0532