FDA inspection

Biora AB: FDA inspection ending May 29, 2008

FDA inspection 525596 · Malmo

Key facts

Inspection ID 525596
Firm Biora AB
FEI number 3002806508
Address Amersham Health R&D Ab, Medeon Science Park
City Malmo
Fiscal year 2008
Inspection end date May 29, 2008
Project area Compliance: Med Devices
Product type Devices

At a glance

  • None Citations
  • None 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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