FDA inspection

Ortho Clinical Diagnostics Gmbh: FDA inspection ending Jul 7, 2016

FDA inspection 981517 · No Action Indicated (NAI) · Neckargemund

Key facts

Inspection ID 981517
Firm Ortho Clinical Diagnostics Gmbh
FEI number 3001665564
Address Karl-Landsteiner-Str. 1
City Neckargemund
Country Germany
Fiscal year 2016
Inspection end date Jul 7, 2016
Classification No Action Indicated (NAI)
Project area Compliance: Devices
Product type Devices

At a glance

  • None Citations
  • None Posted citations
  • No Warning letter followed
  • No 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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