FDA inspection

Ace Medical: FDA inspection ending Jan 24, 2013

FDA inspection 818870 · Official Action Indicated (OAI) · Goyang

Key facts

Inspection ID 818870
Firm Ace Medical
FEI number 3005126704
Address 33 Naeyugil124beon-Gil; Deogyang
City Goyang
Country Korea (the Republic of)
Fiscal year 2013
Inspection end date Jan 24, 2013
Classification Official Action Indicated (OAI)
Project area Compliance: Devices
Product type Devices
Warning letter 394059

At a glance

  • 1–9 Citations
  • 1–9 Posted citations
  • Yes Warning letter followed
  • Yes Form FDA 483 issued
  • Yes 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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