FDA inspection

Image Monitoring USA Inc.: FDA inspection ending Feb 6, 2020

FDA inspection 1117011 · Voluntary Action Indicated (VAI) · Buffalo, NY

Key facts

Inspection ID 1117011
Firm Image Monitoring USA Inc.
FEI number 3014171825
Address 1051 Clinton St
City Buffalo
State NY
ZIP 14206
Country United States
Fiscal year 2020
Inspection end date Feb 6, 2020
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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