483
NerPharMa S.r.l.FDA 483 - NerPharMa S.r.l. - June 27, 2025
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Record Details
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.
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ID · 8fe3528c-de7e-4811-9cbd-81f9a82addb1