FDA inspection

Medtronic Sofamor Danek Usa, Inc - Dallas Distribution: FDA inspection ending Mar 22, 2017

FDA inspection 1013502 · No Action Indicated (NAI) · Haltom City, TX

Key facts

Inspection ID 1013502
Firm Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
FEI number 1625507
Address 4620 N Beach St
City Haltom City
State TX
ZIP 76137-3219
Fiscal year 2017
Inspection end date Mar 22, 2017
Classification No Action Indicated (NAI)
Project area Compliance: 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.

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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