Company
United StatesLumiQuick Diagnostics Inc., Santa Clara, CA – FDA Inspections
Inspection records and compliance data for LumiQuick Diagnostics Inc. in Santa Clara, California. 5 FDA inspections on record (2 OAI), 2 warning letters, last inspected November 05, 2025.
Company Profile
This profile covers LumiQuick Diagnostics Inc. based in Santa Clara, California, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 2
- VAI
- 0
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 2
First inspected December 7, 2012. Last inspected November 5, 2025.
Most cited issue areas
- Environmental control Lack of or inadequate procedures1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 5, 2025 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1295738 |
| November 17, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 949462 |
| July 24, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 935468 |
| February 24, 2014 | OAI | Medical Devices & Rad Health · Compliance: Devices | 867537 |
| December 7, 2012 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 809900 |
FDA documents
Warning Letters (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
LumiQuick Diagnostics Inc.
FEI Number
3005984081
Address
2946 Scott Blvd, Santa Clara, California 95054, United States
Country
United States
ID: 04511435-12aa-4d1d-8902-602abcd2ca12