FDA 483 - Amol Pharmaceuticals Private Ltd. - September 13, 2019

Amol Pharmaceuticals Private Ltd., an OTC drug product manufacturer in Sanganer, Jaipur, India, was cited for significant deficiencies in its production and process controls. The inspection revealed a lack of written procedures, unestablished process parameters for US marketed products, and a deficient hold time study. These issues raise concerns about the identity, strength, quality, and purity of their drug products.