FDA 483 - GRANULES LIFE SCIENCES PRIVATE LIMITED - August 01, 2025

An FDA inspection of Granules Life Sciences Pvt. Ltd. in Medchal-Malkajgiri District, India, revealed critical deficiencies in computer system controls. The firm failed to ensure that only authorized personnel could institute changes to master production and control records or other records. This serious lapse was primarily due to the widespread use of shared usernames and passwords across various Human Mechanical Interface (HMI) systems and laboratory testing equipment, impacting the integrity of drug product manufacturing and testing data.