FDA inspection

ShinChang Medical Co., Ltd.: FDA inspection ending Jul 29, 2005

FDA inspection 391861 · Voluntary Action Indicated (VAI) · Gumi

Key facts

Inspection ID 391861
Firm ShinChang Medical Co., Ltd.
FEI number 3003169040
Address 144 1gongdan-Ro
City Gumi
Fiscal year 2005
Inspection end date Jul 29, 2005
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Med Devices
Product type Devices

At a glance

  • None 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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