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

An FDA inspection of Pinnacle Life Science Private Limited, a drug manufacturer located in Solan, Himachal Pradesh, India, was conducted from April 16 to April 22, 2024. The inspection resulted in the issuance of a Form FDA 483, identifying multiple violations of Current Good Manufacturing Practices (cGMP) that impact the integrity, safety, and quality of drug products.

The main issues observed centered on data integrity and control. The firm lacked appropriate controls for computer-acquired data, including undocumented manual HMI data backups and missing procedures for backup, restoration, and verification. Criticality of production equipment alarms was not determined, and electronic review of alarms and audit trails was not performed. A Gas Chromatography instrument was also used for routine testing without complete computer software validation.

Further observations included deficiencies in equipment qualification, specifically the incomplete critical functionality testing during operational qualification for certain production machinery. Facility maintenance was found lacking, with no hot water available in the men's washroom of a gowning area. Laboratory controls were inadequate, as analytical method validation protocols for drug products did not specify filter compatibility or intermediate precision methods. The quality system also exhibited weaknesses, including a failure to follow established procedures for data backup and restoration, absence of a procedure for reviewing electronic microbiology media data, and insufficient documentation of required cGMP refresher training for employees. Pinnacle Life Science Private Limited is required to develop and implement comprehensive corrective actions to address these observations and ensure regulatory compliance.