Bredent GmbH & Co. KG, Senden, Germany – FDA Inspections

Inspection records and compliance data for Bredent GmbH & Co. KG in Senden. 2 FDA inspections on record, last inspected September 19, 2013.

Company Profile

This profile covers Bredent GmbH & Co. KG based in Senden, Germany.

FDA Inspection History

FDA inspections: 2
OAI: 0
VAI: 2
NAI: 0
Form 483s: 0
Warning letters: 0

First inspected July 29, 2010. Last inspected September 19, 2013.

Most cited issue areas

Documentation of software validation1 inspection

FDA inspections (2)

Date	Result	FDA center(s)	Insp. #
September 19, 2013	VAI	Medical Devices & Rad Health · Compliance: Devices	852293
July 29, 2010	VAI	Medical Devices & Rad Health · Compliance: Devices	677216

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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