FDA 483 - MEDICA S.p.A. Socio Unico - November 15, 2024

An FDA inspection of MEDICA S.p.A. Socio Unico, a medical device manufacturer in Medolla, Italy, revealed significant deficiencies in its quality system. The firm failed to establish adequate procedures for complaint handling and medical device reporting, and its personnel lacked necessary training on US FDA regulations for medical devices. These issues indicate a broad lack of understanding and implementation of critical regulatory requirements for devices intended for the US market.