FDA inspection

Orthofix U.S. LLC: FDA inspection ending Dec 16, 2009

FDA inspection 643401 · No Action Indicated (NAI) · Lewisville, TX

Key facts

Inspection ID 643401
Firm Orthofix U.S. LLC
FEI number 2183449
Address 3451 Plano Pkwy
City Lewisville
State TX
ZIP 75056
Country United States
Fiscal year 2010
Inspection end date Dec 16, 2009
Classification No Action Indicated (NAI)
Project area Human Cellular, Tissue, and Gene Therapies
Product type Biologics

At a glance

  • None Citations
  • None Posted citations
  • No Warning letter followed
  • No Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 10–99 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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