FDA inspection

Biora AB: FDA inspection ending Apr 18, 2013

FDA inspection 831559 · Administrative/Directed Change (ADC) · Malmo

Key facts

Inspection ID	831559
Firm	Biora AB
FEI number	3002806508
Address	Amersham Health R&D Ab, Medeon Science Park
City	Malmo
Fiscal year	2013
Inspection end date	Apr 18, 2013
Classification	Administrative/Directed Change (ADC)
Project area	Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Product Evaluation: Med Devices\|Product Evaluation: Medical 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.

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Source: U.S. Food and Drug Administration (FDA), inspection classification data

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