Orca1

FDA inspection

Lutonix Inc.: FDA inspection ending Jan 25, 2019

FDA inspection 1077874 · No Action Indicated (NAI) · Tempe, Arizona

Key facts

Inspection ID 1077874
Firm Lutonix Inc.
FEI number 3006513822
Address 9409 Science Center Dr
City Tempe
State Arizona
ZIP 85281
Fiscal year 2019
Inspection end date Jan 25, 2019
Classification No Action Indicated (NAI)
Project area Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices|Compliance: Med Devices|Compliance: Medical Devices|Postmarket Assurance: Devices|Postmarket Assurance: Med Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Med Devices|Product Evaluation: Medical Devices
Product type Devices

At a glance

  • None Citations
  • None 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.

Other inspections at this establishment

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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