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

During an FDA inspection conducted from April 16-22, 2024, drug manufacturer Pinnacle Life Science Private Limited in Solan, Himachal Pradesh, India, received a Form FDA-483, detailing significant observations regarding its quality systems and Good Manufacturing Practices. The inspection revealed critical deficiencies across several areas. A primary concern was the lack of appropriate controls for computer-acquired data and related systems, compromising data integrity for both manufacturing and laboratory equipment. Specific issues included undocumented data backups, use of unvalidated software for routine testing, and failure to electronically review alarms and audit trails for production batches. Furthermore, routine equipment qualification was found to be deficient, with critical functionality testing not fully performed. Facility maintenance was also inadequate, exemplified by the absence of hot water in a critical gowning area washroom, essential for personnel hygiene. In the laboratory, analytical method validation protocols were deemed insufficient, lacking necessary details for ensuring product identity, strength, quality, and purity. The firm's quality control unit also exhibited non-compliance, failing to consistently follow data backup and restoration procedures, adequately review electronic microbiology data, and document required cGMP training for employees. These observations indicate a clear need for Pinnacle Life Science Private Limited to implement comprehensive corrective actions to address data integrity, equipment qualification, facility upkeep, laboratory controls, and overall quality system adherence, ensuring full compliance with regulatory requirements for drug manufacturing.