FDA inspection

Bio Protech, Inc.: FDA inspection ending Dec 9, 2010

FDA inspection 704336 · Voluntary Action Indicated (VAI) · Wonju-Si

Key facts

Inspection ID 704336
Firm Bio Protech, Inc.
FEI number 3003514332
Address Donghwa Medical Instrument Complex, 1654-7 Donghwa-Ri Munmak-Eup
City Wonju-Si
Country Korea (the Republic of)
Fiscal year 2011
Inspection end date Dec 9, 2010
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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