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FDA Inspection
•R82 A/S•June 7, 2013

R82 A/S – FDA Inspection, Jun 7, 2013

Record Details

This FDA Inspection record concerns R82 A/S, with an inspection on June 7, 2013, issued by the Center for Devices and Radiological Health, covering devices.

Company
R82 A/S
Inspection Date
June 7, 2013
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · c8f263dd-b665-4c8c-bceb-577d6e7f0a13

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
839344
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

Other FDA inspections of R82 A/S

2
DateClassificationOfficeProject area
November 1, 2018VAICenter for Devices and Radiological HealthCompliance: Devices
October 7, 2010VAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
Other documents for R82 A/S
  • FDA Inspection 1070529 - 2018-11-01
  • FDA Inspection 697737 - 2010-10-07

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