FDA 483 - Fresenius Kabi Oncology Limited - October 10, 2023

An FDA inspection of Fresenius Kabi Oncology Limited in Solan, India, revealed significant deficiencies across its sterile injectable drug manufacturing operations. Key issues include widespread failures in aseptic processing practices, falsification of environmental monitoring records, and inadequate validation of critical manufacturing steps. The findings indicate a serious lack of control over processes designed to ensure product sterility and data integrity.