FDA 483 - Alembic Pharmaceuticals Limited (Units I and II) - May 26, 2025
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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.
ID · 572804fe-e82a-4cba-8325-58bdcf2ed319