FDA inspection

Coloplast Hungary, KFT.: FDA inspection ending Jun 25, 2009

FDA inspection 607321 · Official Action Indicated (OAI) · Nyirbator

Key facts

Inspection ID 607321
Firm Coloplast Hungary, KFT.
FEI number 3006606901
Address Coloplast Ut 2
City Nyirbator
Country Hungary
Fiscal year 2009
Inspection end date Jun 25, 2009
Classification Official Action Indicated (OAI)
Project area Compliance: Devices
Product type Devices

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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