FDA inspection

Orthalign, Inc: FDA inspection ending May 2, 2017

FDA inspection 1014270 · Voluntary Action Indicated (VAI) · Irvine, CA

Key facts

Inspection ID 1014270
Firm Orthalign, Inc
FEI number 3007521480
Address 120 Columbia Ste 500
City Irvine
State CA
ZIP 92618
Country United States
Fiscal year 2017
Inspection end date May 2, 2017
Classification Voluntary Action Indicated (VAI)
Project area Postmarket Assurance: 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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