Wissner-Bosserhoff GmbH

Warning LetterOpen

Mr. Thomas C. Erbsloeh CEO Wissner-Bosserhoff GmbH Hauptstraβe 4-6 58739 Wickede (Ruhr) GermanyFEI 3015979371Issued Aug 30, 2024Center for Devices and Radiological Health

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Violations7

Issue DateAug 30, 2024

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Wissner-Bosserhoff GmbH
Location: Mr. Thomas C. Erbsloeh CEO Wissner-Bosserhoff GmbH Hauptstraβe 4-6 58739 Wickede (Ruhr) Germany
FEI Number: 3015979371
Country: Germany
Issue Date: August 30, 2024
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

Wissner-Bosserhoff GmbH, a German manufacturer of nursing beds including the Sentida SC model, failed to comply with FDA's Quality System Regulation (21 CFR Part 820) during an April 2024 inspection. The company did not ensure its inspection and test equipment was suitable for its intended purposes or capable of producing valid results, specifically failing to document software validation activities for computer systems used in quality control, such as the electrical-function test station. The FDA determined these nursing beds were adulterated due to inadequate manufacturing controls and processes that deviated from current good manufacturing practice requirements.

Wissner-Bosserhoff GmbH FDA Warning Letter, August 30, 2024