Company
United StatesNeurolumen LLC, Oklahoma City, OK – FDA Inspections
Inspection records and compliance data for Neurolumen LLC in Oklahoma City, Oklahoma. 4 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected September 24, 2025.
Company Profile
This profile covers Neurolumen LLC based in Oklahoma City, Oklahoma, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 1
First inspected December 13, 2013. Last inspected September 24, 2025.
Most cited issue areas
- Lack of or inadequate complaint procedures2 inspections
- Procedures not adequately established or maintained2 inspections
- Purchasing controls, Lack of or inadequate procedures2 inspections
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 24, 2025 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1283200 |
| October 22, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 946577 |
| May 8, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 926041 |
| December 13, 2013 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 859558 |
FDA documents
Form 483s (1)
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Neurolumen LLC
FEI Number
3010144038
Address
9636 N May Ave Ste 230, Oklahoma City, Oklahoma 73120, United States
Country
United States
ID: 2e53eb6e-6247-4069-ade9-cef49b1b8f04