FDA 483 - Orthodent Laboratory, Inc. - March 24, 2021

Orthodent Laboratory, Inc. in Buffalo, NY, a medical device manufacturer, was inspected by the FDA from March 22-24, 2021. The inspection revealed significant deficiencies across its quality system, particularly concerning the manufacture of Vivid Aligners. Key issues included inadequate device master and history records, unvalidated processes and software, insufficient supplier controls, and failures in product acceptance, CAPA, nonconforming product, equipment maintenance, personnel training, and document control.