FDA inspection

FUJIFILM Healthcare Americas Corporation: FDA inspection ending Mar 29, 2018

FDA inspection 1046796 · Voluntary Action Indicated (VAI) · Lexington, MA

Key facts

Inspection ID 1046796
Firm FUJIFILM Healthcare Americas Corporation
FEI number 1000513161
Address 81 Hartwell Ave Ste 300
City Lexington
State MA
ZIP 02421
Country United States
Fiscal year 2018
Inspection end date Mar 29, 2018
Classification Voluntary Action Indicated (VAI)
Project area Project Evaluation: 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
  • 10–99 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

Browse all FDA inspections