FDA inspection

Luminex Corporation: FDA inspection ending Feb 14, 2020

FDA inspection 1117835 · Official Action Indicated (OAI) · Austin, TX

Key facts

Inspection ID 1117835
Firm Luminex Corporation
FEI number 3002524000
Address 12212 Technology Blvd
City Austin
State TX
ZIP 78727
Country United States
Fiscal year 2020
Inspection end date Feb 14, 2020
Classification Official Action Indicated (OAI)
Project area Compliance: Devices
Product type Devices
Warning letter 606267

At a glance

  • 1–9 Citations
  • 1–9 Posted citations
  • Yes Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 1–9 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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