MicroVision, Inc. – FDA 483, May 25, 2023

An FDA inspection of MicroVision, Inc. in Seabrook, NH, a medical device manufacturer, identified significant deficiencies in its employee training procedures and documentation. The firm failed to adequately establish training needs and provide documented evidence of effective training. These issues led to multiple nonconformances and open CAPAs related to various operational procedures, indicating a systemic problem with ensuring employees are sufficiently trained for their manufacturing roles.