FDA inspection

CardioFocus, Inc.: FDA inspection ending May 7, 2015

FDA inspection 928695 · No Action Indicated (NAI) · Marlborough, MA

Key facts

Inspection ID 928695
Firm CardioFocus, Inc.
FEI number 3001451473
Address 500 Nickerson Rd Ste 500-200
City Marlborough
State MA
ZIP 01752
Country United States
Fiscal year 2015
Inspection end date May 7, 2015
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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