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ONTEX HYGIENEARTIKEL DEUTSCHLAND GMBH, Grosspostwitz/O.L., Germany – FDA Inspections

Inspection records and compliance data for ONTEX HYGIENEARTIKEL DEUTSCHLAND GMBH in Grosspostwitz/O.L.. 3 FDA inspections on record (1 OAI), 1 warning letter, last inspected June 21, 2018.

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Company Profile

This profile covers ONTEX HYGIENEARTIKEL DEUTSCHLAND GMBH based in Grosspostwitz/O.L., Germany.

FDA Inspection History

FDA inspections
3
OAI
1
VAI
0
NAI
2
Form 483s
0
Warning letters
1

First inspected April 11, 2013. Last inspected June 21, 2018.

FDA inspections (3)

DateResultFDA center(s)Insp. #
June 21, 2018NAIMedical Devices & Rad Health · Postmarket Assurance: Devices1061002
September 18, 2014NAIMedical Devices & Rad Health · Postmarket Assurance: Devices898920
April 11, 2013OAIMedical Devices & Rad Health · Postmarket Assurance: Devices830498
FDA documents

Warning Letters (1)

  • Warning Letters · April 11, 2013
People (2)
Rene Van De Zande
Person
Steven D. Silverman
Person
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Ulrich Gmbh & Co. KG
Merete GmbH
USHIO GERMANY GmbH
Nephros, Inc.
Trewavis Surgical Instruments Pty Ltd.
Oto Med Inc
Company Information

Name

ONTEX HYGIENEARTIKEL DEUTSCHLAND GMBH

FEI Number

3001019699

Address

Fabrikstr. 30, Grosspostwitz/O.L., Germany

Country

Germany

ID: c30d9b97-f682-4cef-8524-3edb684a51ee

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