FDA inspection

Image Diagnostics, Inc.: FDA inspection ending Apr 18, 2024

FDA inspection 1236226 · Voluntary Action Indicated (VAI) · Fitchburg, MA

Key facts

Inspection ID 1236226
Firm Image Diagnostics, Inc.
FEI number 1000305755
Address 310 Authority Dr
City Fitchburg
State MA
ZIP 01420
Country United States
Fiscal year 2024
Inspection end date Apr 18, 2024
Classification Voluntary Action Indicated (VAI)
Project area Postmarket Assurance: 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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