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

The FDA conducted an inspection of MEDICA S.p.A. Socio Unico, a medical device manufacturer located in Medolla, Italy, from November 11-15, 2024. The inspection revealed several significant compliance issues under the regulatory framework of U.S. FDA regulations, specifically 21 CFR Parts 803, 807, and 820.

Key violations included the absence of established procedures for receiving, reviewing, and evaluating complaints for medical devices exported to the U.S. market, such as their Sterile Hemoconcentrators (K232171). The company also demonstrated a lack of awareness regarding its U.S. market distributors and customers. Additionally, the firm's Medical Device Reporting (MDR) procedure was inadequate, referencing an outdated form instead of requiring electronic submission (eMDR) as mandated by the 2014 Final Rule. Personnel responsible for MDR submissions were unfamiliar with these electronic requirements.

Furthermore, key personnel lacked necessary training and familiarity with critical U.S. FDA regulations pertinent to medical device manufacturers exporting to the U.S., including Medical Device Reporting, Establishment Registration and Device Listing, and Quality System Regulation. In response to these observations, MEDICA S.p.A. Socio Unico committed to correcting all identified deficiencies. This will involve establishing robust complaint handling processes, updating MDR procedures to comply with electronic submission requirements, and implementing comprehensive training on relevant FDA regulations for all affected personnel to ensure full compliance.