FDA inspection

SOMNOmedics AG: FDA inspection ending May 7, 2015

FDA inspection 929266 · Voluntary Action Indicated (VAI) · Randersacker

Key facts

Inspection ID 929266
Firm SOMNOmedics AG
FEI number 3006258337
Address Am Sonnenstuhl 63
City Randersacker
Country Germany
Fiscal year 2015
Inspection end date May 7, 2015
Classification Voluntary Action Indicated (VAI)
Project area Compliance: 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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