FDA 483 - Apicore Pharmaceuticals Private Ltd - May 05, 2023

An FDA inspection of Apicore Pharmaceuticals Private Ltd in Vadodara, India, identified critical deficiencies in their manufacturing operations. The firm failed to adequately validate its aseptic process for sterile drug products, including issues with media fills and disinfectant efficacy studies. Additionally, routine calibration of electronic equipment was not performed according to a written program, indicating a lack of proper quality control.