FDA inspection

Neusoft Medical Systems Co., Ltd.: FDA inspection ending Feb 4, 2016

FDA inspection 957496 · Voluntary Action Indicated (VAI) · Shenyang

Key facts

Inspection ID 957496
Firm Neusoft Medical Systems Co., Ltd.
FEI number 3003575350
Address No. 2 Xiu xiu Street, Hunnan; Sujiatun
City Shenyang
Country China
Fiscal year 2016
Inspection end date Feb 4, 2016
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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