FDA 483 - Icrom Spa - March 18, 2019

An FDA inspection of Icrom S.p.A, an API manufacturer in Concorezzo, Italy, revealed 10 observations concerning significant deficiencies in their manufacturing and quality control systems. Key issues included inadequate cleaning procedures, lack of proper quality unit oversight, poor documentation practices, and insufficient investigation of discrepancies. These findings indicate a potential risk to product quality and purity due to a lack of robust controls.