FDA Inspection
LumiQuick Diagnostics Inc.LumiQuick Diagnostics Inc. – FDA Inspection, Dec 7, 2012
Record Details
This FDA Inspection record concerns LumiQuick Diagnostics Inc., with an inspection on December 7, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- LumiQuick Diagnostics Inc.
- Inspection Date
- December 7, 2012
- Product Type
- Devices
View Company Profile
ID · df045863-a951-4a3d-90b3-f5e3e2aae3b9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 809900
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of LumiQuick Diagnostics Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 5, 2025 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 17, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 24, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 24, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for LumiQuick Diagnostics Inc.
- FDA Inspection 1295738 - 2025-11-05
- FDA Inspection 949462 - 2015-11-17
- FDA Inspection 935468 - 2015-07-24
- FDA Inspection 867537 - 2014-02-24
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