FDA inspection

Image Diagnostics, Inc.: FDA inspection ending Oct 16, 2015

FDA inspection 946871 · Voluntary Action Indicated (VAI) · Fitchburg, MA

Key facts

Inspection ID 946871
Firm Image Diagnostics, Inc.
FEI number 1000305755
Address 310 Authority Dr
City Fitchburg
State MA
ZIP 01420
Country United States
Fiscal year 2016
Inspection end date Oct 16, 2015
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Devices
Product type Devices

At a glance

  • 1–9 Citations
  • 1–9 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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