FDA inspection

Cochlear Bone Anchored Solutions AB: FDA inspection ending Oct 12, 2017

FDA inspection 1051950 · Voluntary Action Indicated (VAI) · Molnlycke

Key facts

Inspection ID 1051950
Firm Cochlear Bone Anchored Solutions AB
FEI number 3003222064
Address Konstruktionsvagen 14
City Molnlycke
Fiscal year 2018
Inspection end date Oct 12, 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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