FDA inspection

EONE Laboratories: FDA inspection ending Apr 9, 2019

FDA inspection 1086218 · Voluntary Action Indicated (VAI) · Yeonsu District

Key facts

Inspection ID 1086218
Firm EONE Laboratories
FEI number 3012094568
Address 49 Songdong
City Yeonsu District
Country Korea (the Republic of)
Fiscal year 2019
Inspection end date Apr 9, 2019
Classification Voluntary Action Indicated (VAI)
Project area Human Cellular, Tissue, and Gene Therapies
Product type Biologics

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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