Company
United StatesLumitex Medical Devices Inc, Strongsville, OH – FDA Inspections
Inspection records and compliance data for Lumitex Medical Devices Inc in Strongsville, Ohio. 4 FDA inspections on record, 1 Form 483, last inspected May 01, 2026.
Company Profile
This profile covers Lumitex Medical Devices Inc based in Strongsville, Ohio, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 0
- NAI
- 4
- Form 483s
- 1
- Warning letters
- 0
First inspected June 22, 2011. Last inspected May 1, 2026.
Most cited issue areas
- Complaint handling procedures not documented1 inspection
- Control over outsourced processes not proportionate to risk1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 1, 2026 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1315326 |
| January 9, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1000208 |
| December 26, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 859893 |
| June 22, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 730676 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Lumitex Medical Devices Inc
FEI Number
1000122810
Address
8443 Dow Cir, Strongsville, Ohio 44136, United States
Country
United States
ID: 19fa724c-17a2-4f62-a576-8e27c8b303d1