FDA inspection

Atos Medical AB: FDA inspection ending Sep 22, 2017

FDA inspection 1044100 · Voluntary Action Indicated (VAI) · Horby

Key facts

Inspection ID 1044100
Firm Atos Medical AB
FEI number 3002806269
Address Kraftgatan 8
City Horby
Fiscal year 2017
Inspection end date Sep 22, 2017
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Medical 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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