483
Human Biosciences, Inc.Human Biosciences, Inc. – FDA 483, Feb 15, 2022
Record Details
Human Biosciences, Inc. in Gaithersburg, MD, a medical device manufacturer, was cited for three observations during an FDA inspection. The inspection revealed deficiencies in design control, specifically regarding inadequate documentation of design output for their SkinTemp® II device and a lack of established procedures for design reviews. Additionally, the firm failed to establish adequate rework procedures for nonconforming products.
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ID · 36857491-ce86-4d91-8208-3c8fe12a2906
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