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Bernd Richter GmbH, Wipperfurth, Germany – FDA Inspections

Inspection records and compliance data for Bernd Richter GmbH in Wipperfurth. 2 FDA inspections on record, 2 Form 483s, last inspected February 16, 2023.

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Company Profile

This profile covers Bernd Richter GmbH based in Wipperfurth, Germany.

FDA Inspection History

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

First inspected June 29, 2017. Last inspected February 16, 2023.

Most cited issue areas

  • DHR - not or inadequately maintained1 inspection
  • Lack/Inad procedure-Monitoring/Control of Validated Proces1 inspection
  • Lack of or inadequate In-process acceptance procedures1 inspection

FDA inspections (2)

DateResultFDA center(s)Insp. #
February 16, 2023VAIMedical Devices & Rad Health · Compliance: Devices1198120
June 29, 2017Not classifiedMedical Devices & Rad Health · Compliance: Devices1017385
FDA documents

Form 483s (1)

  • Form 483s · February 16, 2023
People (1)
Tiki Dixon
Person
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Company Information

Name

Bernd Richter GmbH

FEI Number

3004035727

Address

Hansestr. 4, Wipperfurth, Germany

Country

Germany

ID: 412d5fc6-4581-420a-9bd5-3f99b9a8e273

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