FDA 483 - Centaur Pharmaceuticals Private Ltd. - February 08, 2023

Centaur Pharmaceuticals Private Ltd. in Hinjewadi, India, was cited with four observations during an FDA inspection, revealing significant deficiencies in equipment cleaning and design, leading to potential cross-contamination of drug products. The firm's laboratory controls were also found to be inadequate, including issues with analytical method validation and insufficient investigation into extraneous peaks. These findings indicate a serious lack of adherence to cGMP regulations, impacting product quality and patient safety.