FDA inspection

GenMark Diagnostics, Inc.: FDA inspection ending Feb 23, 2006

FDA inspection 428512 · No Action Indicated (NAI) · Carlsbad, CA

Key facts

Inspection ID 428512
Firm GenMark Diagnostics, Inc.
FEI number 3008632402
Address 5964 La Place Ct Ste 100
City Carlsbad
State CA
ZIP 92008-8829
Fiscal year 2006
Inspection end date Feb 23, 2006
Classification No Action Indicated (NAI)
Project area Compliance: Med 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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