FDA 483 - Pinnacle Life Science Private Limited - April 22, 2024

During an FDA inspection conducted from April 16 to April 22, 2024, Pinnacle Life Science Private Limited in Solan, Himachal Pradesh, India, a drug manufacturer, received a Form FDA 483 citing multiple significant observations related to current Good Manufacturing Practices (cGMP). Key issues identified primarily involved data integrity and control systems. The firm lacked appropriate controls for computer-acquired data, failing to ensure changes and access were restricted to authorized personnel, and couldn't guarantee the accuracy of data from manufacturing and laboratory equipment. Specifically, manual HMI data backups were undocumented, procedures for backup/restoration were absent, and critical alarms were not assessed. Furthermore, electronic review of alarms and audit trails was not performed, and a Gas Chromatography instrument was used for routine testing without complete software validation. Other observations included deficiencies in routine equipment calibration and qualification, specifically inadequate critical functionality testing during operational qualification for manufacturing equipment. Facility maintenance was also an issue, with a lack of hot water in men's washroom in a gowning area, which impacts hygiene practices. Laboratory controls were found wanting due to inadequate analytical method validation protocols lacking details on filter compatibility and intermediate precision. Lastly, the quality control unit failed to follow established procedures for data backup, restoration review, electronic data review for microbiology media, and ensuring documentation of required refresher cGMP training for employees. Pinnacle Life Science Private Limited is required to thoroughly address these observations and implement comprehensive corrective and preventive actions to ensure compliance with cGMP regulations and maintain product quality and safety.