FDA 483 - Megafine Pharma (P) Limited - January 24, 2023

This FDA Form 483 report details significant deficiencies at Megafine Pharma (P) Ltd. related to their manufacturing of Active Pharmaceutical Ingredients (APIs). The firm's quality unit failed to ensure CGMP compliance, with issues spanning inadequate cleaning validation, poor data integrity practices, and ineffective investigation processes. Observations also highlight problems with equipment maintenance, non-contemporaneous batch record keeping, and insufficient controls in packaging and laboratory operations.