FDA inspection

Luminex Molecular Diagnostics Inc: FDA inspection ending May 4, 2018

FDA inspection 1078209 · Voluntary Action Indicated (VAI) · Toronto

Key facts

Inspection ID 1078209
Firm Luminex Molecular Diagnostics Inc
FEI number 3002777243
Address 439 University Ave Suite 900
City Toronto
Fiscal year 2018
Inspection end date May 4, 2018
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Medical Devices
Product type Devices

At a glance

  • None Citations
  • 1–9 Posted citations
  • No 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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