FDA 483 - Amneal Pharmaceuticals Private Ltd. - June 19, 2024

Amneal Pharmaceuticals Private Ltd., Parenteral Unit in Ahmedabad, India, was cited for significant deficiencies in its manufacturing processes for sterile drug products. Observations included inadequate production and process controls, insufficient validation of aseptic processes, and failures in process validation studies and equipment calibration. These issues indicate a lack of robust quality assurance for sterile drug product manufacturing.