FDA inspection

Bistos Co Ltd: FDA inspection ending Sep 27, 2012

FDA inspection 804127 · Voluntary Action Indicated (VAI) · Yongin

Key facts

Inspection ID 804127
Firm Bistos Co Ltd
FEI number 3006179052
Address 7th Floor, A Bldg, Woolim Lions Valley 5, 144-3, Sangdaewon-Dong, Jungwon-Gu
City Yongin
Country Korea (the Republic of)
Fiscal year 2012
Inspection end date Sep 27, 2012
Classification Voluntary Action Indicated (VAI)
Project area Compliance: 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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