FDA 483 - Wright Medical Technology Inc - September 29, 2021

An FDA inspection of Wright Medical Technology Inc. in Arlington, TN, revealed significant deficiencies in their quality system. The firm failed to adequately control nonconforming products, including mislabeled or mispackaged devices, and did not timely investigate potential field actions. Additionally, the inspection found inadequate procedures for monitoring validated process parameters, specifically regarding timely initiation of nonconforming events for bioburden excursions, and a failure to conduct complaint investigations within established timelines.