FDA inspection

Czech-Gen, a.s.: FDA inspection ending Dec 14, 2012

FDA inspection 814196 · Voluntary Action Indicated (VAI) · Olomouc

Key facts

Inspection ID 814196
Firm Czech-Gen, a.s.
FEI number 3002806982
Address Na Vlcinci 16/3
City Olomouc
Country Czech Republic
Fiscal year 2013
Inspection end date Dec 14, 2012
Classification Voluntary Action Indicated (VAI)
Project area Drug Quality Assurance
Product type Drugs

At a glance

  • None 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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