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

During an inspection conducted from April 16-22, 2024, the FDA issued a Form 483 to Pinnacle Life Science Private Limited, a drug manufacturer located in Solan, Himachal Pradesh, India. The inspection revealed significant concerns regarding the firm's adherence to Current Good Manufacturing Practices (cGMP). Key observations highlighted issues across multiple systems. The facilities and equipment system showed a lack of appropriate controls for computer-acquired data, with insufficient data backup procedures, unverified data restoration, and unvalidated software for laboratory instruments like Gas Chromatography. Equipment qualification was also deficient, specifically for critical functionality testing. Additionally, the men's washroom in the gowning area lacked hot water, impacting hygiene. Laboratory controls were found inadequate, with analytical method validation protocols lacking critical details for related substances testing. Furthermore, the quality system exhibited failures in following standard operating procedures for data backup and restoration, an absence of procedures for reviewing electronic microbiology media data, and undocumented cGMP refresher training for employees. These observations indicate that the firm's quality system cannot adequately ensure the accuracy and integrity of data necessary to support product safety, effectiveness, and quality. Pinnacle Life Science Private Limited is required to respond to the FDA with comprehensive corrective actions to address these deficiencies and ensure compliance with regulatory standards.