FDA inspection

ShinChang Medical Co., Ltd.: FDA inspection ending Jun 19, 2008

FDA inspection 527618 · No Action Indicated (NAI) · Gumi

Key facts

Inspection ID 527618
Firm ShinChang Medical Co., Ltd.
FEI number 3003169040
Address 144 1gongdan-Ro
City Gumi
Fiscal year 2008
Inspection end date Jun 19, 2008
Classification No Action Indicated (NAI)
Project area Compliance: Med Devices
Product type Devices

At a glance

  • None Citations
  • None 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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