FDA 483 - Nical S.p.A. - May 30, 2018

An FDA inspection of Nical S.p.A., a medical device manufacturer in Milan, Italy, revealed significant deficiencies in its quality system. The firm was cited for inadequate risk analysis, a lack of written medical device reporting procedures, and failures in its corrective and preventive action system. Additionally, procedures for device history records were found to be deficient, specifically regarding the inclusion of labeling.