FDA inspection

NanoEnTek Factory: FDA inspection ending Jun 10, 2016

FDA inspection 979221 · Voluntary Action Indicated (VAI) · Suwon,

Key facts

Inspection ID 979221
Firm NanoEnTek Factory
FEI number 3007349751
Address 851-14 Seohae-ro Paltan-myeon, Hwaseong-si Gyeonggi-do
City Suwon,
Country Korea (the Republic of)
Fiscal year 2016
Inspection end date Jun 10, 2016
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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