FDA 483 - TRUE DIAGNOSTICS, INC - March 09, 2022

TRUE DIAGNOSTICS, INC in Carlsbad, CA received a Form FDA-483 with six observations following an inspection from March 2-9, 2022. The firm was cited for significant deficiencies in its quality system, including a lack of process and equipment validation, inadequate environmental controls, and failures in establishing and maintaining critical procedures for in-process product, device history records, purchasing, and document control. These issues collectively indicate a broad breakdown in the firm's adherence to cGMP regulations for medical device manufacturing.