FDA 483 - Amol Pharmaceuticals Private Ltd. - February 16, 2018

The FDA inspection of Amol Pharmaceuticals Private Ltd. in Sanganer, India, revealed severe deficiencies across its quality control, production, and facility systems. Key issues included unreliable raw data, inadequate investigations into stability excursions and unknown contaminants, and unvalidated analytical methods and electronic systems. The firm also demonstrated poor documentation practices, incomplete equipment cleaning validation, unrecorded procedural deviations, and a lack of adequately trained personnel, indicating a systemic failure to ensure the quality and purity of drug products.