FDA Inspection 1195245 — Luminex Corporation

Luminex Corporation — FEI 3006028115

The FDA completed an inspection of Luminex Corporation on January 20, 2023 in Northbrook, IL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
January 20, 2023
Fiscal Year
2023
Product Type
Devices
Project Area
Compliance: Devices
Location
Northbrook, IL (United States)

Citations

IDCFRDescription
63021 CFR 803.17Lack of Written MDR Procedures