FDA 483 - St. Jude Medical, Atrial Fibrillation Division, Inc. - March 29, 2019

An FDA inspection of Abbott Laboratories Inc. (St Jude Medical) in Saint Paul, MN, revealed significant deficiencies in design control processes, particularly concerning the transfer and verification of OEM components. The firm failed to adequately establish design plans, verify design inputs, and document design outputs before release. These issues indicate a breakdown in critical quality system elements for medical device manufacturing.