FDA 483 - Human Biosciences, Inc. - February 15, 2022

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.