FDA Inspection
Luminex CorporationLuminex Corporation – FDA Inspection, Jan 13, 2023
Record Details
This FDA Inspection record concerns Luminex Corporation, with an inspection on January 13, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e7244dbc-2e96-4f96-b26c-16fdeba4020b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1195233
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Luminex Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 14, 2020 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 6, 2018 | Not classified | Dallas District Office | |
| February 15, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 9, 2009 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for Luminex Corporation
- FDA Inspection 1117835 - 2020-02-14
- FDA Inspection 1079277 - 2018-04-06
- FDA Inspection 768656 - 2012-02-15
- FDA Inspection 561479 - 2009-02-09
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