FDA Inspection
Lumitex Medical Devices IncLumitex Medical Devices Inc – FDA Inspection, May 1, 2026
Record Details
This FDA Inspection record concerns Lumitex Medical Devices Inc, with an inspection on May 1, 2026, issued by the Cincinnati District Office, covering medical devices & rad health.
- Company
- Lumitex Medical Devices Inc
- Inspection Date
- May 1, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · d59a1748-59bb-48f9-90ee-10806170a1dc
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1315326
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- ISO 13485:2016 Clause 4.1.5Control over outsourced processes not proportionate to risk
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Lumitex Medical Devices Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 9, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 26, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 22, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Lumitex Medical Devices Inc
- FDA Inspection 1000208 - 2017-01-09
- FDA Inspection 859893 - 2013-12-26
- FDA Inspection 730676 - 2011-06-22
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.