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

During an FDA inspection conducted from November 11-15, 2024, the firm MEDICA S.p.A. Socio Unico, a medical device manufacturer in Medolla, Italy, received a Form FDA 483 citing several significant observations regarding its quality system and regulatory compliance for devices intended for the U.S. market. The primary issues identified include a lack of established procedures for receiving, reviewing, and evaluating customer complaints for U.S.-exported medical devices. Specifically, the firm failed to ensure proper assessment of complaints to determine if they necessitated Medical Device Reporting (MDR) under 21 CFR Part 803. Furthermore, the company was unable to provide information on its U.S. market distributors and customers for its own-brand devices, such as the Class II Sterile Hemoconcentrators (K232171). A second key observation noted that the firm's written MDR procedure was inadequate. It incorrectly referenced Form FDA 3500A instead of adhering to the electronic Medical Device Reporting (eMDR) requirements, and personnel were unfamiliar with eMDR protocols. Finally, the FDA observed that key personnel lacked essential training and familiarity with critical U.S. FDA regulations pertinent to medical device manufacturers exporting to the U.S., including 21 CFR Part 803 (MDR), 21 CFR Part 807 (Establishment Registration and Device Listing), and 21 CFR Part 820 (Quality System Regulation). MEDICA S.p.A. has committed to correcting all identified observations.