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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.