FDA inspection

audifon GmbH & Co. KG: FDA inspection ending Dec 18, 2019

FDA inspection 1114379 · Voluntary Action Indicated (VAI) · Kolleda

Key facts

Inspection ID 1114379
Firm audifon GmbH & Co. KG
FEI number 3006076696
Address Werner-von-Siemens-Str. 2
City Kolleda
Country Germany
Fiscal year 2020
Inspection end date Dec 18, 2019
Classification Voluntary Action Indicated (VAI)
Project area Postmarket Assurance: 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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