FDA 483 - Skyline Medical, Inc. - October 01, 2019

An FDA inspection of Skyline Medical, Inc., a medical device manufacturer in Eagan, MN, revealed significant deficiencies in its corrective and preventive action (CAPA) procedures. The firm failed to adequately establish and follow CAPA processes, leading to unverified corrective actions, uncompleted change orders for critical component replacements, and numerous open CAPAs without documented activity. These issues indicate a breakdown in the quality system for addressing product nonconformities and ensuring product quality.