FDA inspection

Biotronik, AG: FDA inspection ending May 23, 2008

FDA inspection 527810 · Voluntary Action Indicated (VAI) · Bulach

Key facts

Inspection ID 527810
Firm Biotronik, AG
FEI number 3002808050
Address Ackerstrasse 6
City Bulach
Fiscal year 2008
Inspection end date May 23, 2008
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Med Devices
Product type Devices

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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