FDA 483 - NerPharMa S.r.l. - June 27, 2025

The FDA inspected NerPharMa S.r.l. in Nerviano, Milan, Italy, a drug manufacturer, and identified significant deficiencies. The observations primarily concern inadequate aseptic processing controls, environmental monitoring, cleaning procedures, and a lack of robust investigation and quality control systems. These issues indicate a failure to ensure the sterility, purity, and quality of drug products.