FDA Inspection
Luminex CorporationLuminex Corporation – FDA Inspection, Jan 20, 2023
Record Details
This FDA Inspection record concerns Luminex Corporation, with an inspection on January 20, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · eda149eb-a097-4c60-a3ab-322da99c171b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1195245
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Luminex Corporation
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 22, 2021 | VAI | Center for Devices and Radiological Health | Compliance: 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 1155192 - 2021-10-22
- 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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