FDA Inspection
Luminex CorporationLuminex Corporation – FDA Inspection, Oct 22, 2021
Record Details
This FDA Inspection record concerns Luminex Corporation, with an inspection on October 22, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Luminex Corporation
- Inspection Date
- October 22, 2021
- Product Type
- Devices
View Company Profile
ID · baa929dc-d140-453f-9c94-b31c3d1d1283
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1155192
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Luminex Corporation
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 20, 2023 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 14, 2020 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 17, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 18, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 4, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Luminex Corporation
- FDA Inspection 1195245 - 2023-01-20
- FDA Inspection 1117864 - 2020-02-14
- FDA Inspection 1005213 - 2017-03-17
- FDA Inspection 958073 - 2015-11-18
- FDA Inspection 874256 - 2014-04-04
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