FDA 483 - Alembic Pharmaceuticals Limited (Units I and II) - May 26, 2025

Alembic Pharmaceuticals Limited (Units I and II) in Halol, Gujarat, India, an API manufacturer, was cited for significant deficiencies across its quality and laboratory control systems. Observations included untimely and inadequate laboratory investigations, unvalidated stability-indicating test procedures, poorly maintained and cleaned equipment, and a lack of Quality Unit oversight on GMP documentation. These issues indicate a systemic failure to ensure the quality and purity of drug substances.