CIRON DRUGS AND PHARMACEUTICALS PVT LTD – FDA 483, Apr 25, 2023

Ciron Drugs and Pharmaceuticals Private Limited, a manufacturer in Tarapur, India, received a Form 483 for two significant observations. The firm's aseptic process validation was deemed inadequate due to an incomplete disinfectant efficacy study. Additionally, in-process materials were not properly tested, and bulk hold time studies were deficient, lacking critical documentation and stability evaluations for finished drug products.