FDA inspection

Barox Co., Ltd.: FDA inspection ending May 18, 2018

FDA inspection 1052335 · Official Action Indicated (OAI) · Jungwon, Seongnam

Key facts

Inspection ID 1052335
Firm Barox Co., Ltd.
FEI number 3010166805
Address Jungwon, Hallasigma 545 Dunchon-Daero
City Jungwon, Seongnam
Country Korea (the Republic of)
Fiscal year 2018
Inspection end date May 18, 2018
Classification Official Action Indicated (OAI)
Project area Drug Quality Assurance
Product type Drugs
Warning letter 565314

At a glance

  • 1–9 Citations
  • 1–9 Posted citations
  • Yes 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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