FDA 483 - NATCO Pharma Limited - June 19, 2025

An FDA inspection of NATCO Pharma Limited in Rangareddy, India, a sterile and non-sterile drug manufacturer, revealed significant deficiencies across its aseptic processing operations and quality control systems. Key issues included severe data integrity problems with environmental monitoring, inadequate aseptic process validation, poor facility maintenance, and a lack of thorough investigations into discrepancies and quality events. The findings indicate a systemic breakdown in quality oversight and adherence to cGMP requirements, particularly concerning sterile drug product manufacturing.