FDA 483 - JNTL Consumer Health (India) Private Limited - April 17, 2024

During an inspection from April 15-17, 2024, the FDA issued a Form 483 to JNTL Consumer Health (India) Private Limited, a control testing laboratory in Mumbai. The inspection revealed two significant observations related to the company's operational and quality systems. Firstly, the facility failed to ensure proper performance of electronic equipment. There was no written program or impact assessment to address potential data loss or equipment damage from power supply issues like voltage fluctuations, despite multiple internal investigations identifying these as likely causes of equipment failures. The preventative maintenance program was also found insufficient, relying on fixed intervals even when equipment failures occurred outside these schedules, without adjustments to protocols. Secondly, deviations from written laboratory procedures were not adequately justified. Numerous laboratory investigations, including those for out-of-specification results and incidents, exceeded their established closure timelines. Both site-specific and global procedures for handling non-conformances and corrective actions were deemed inadequate, as they permitted extensions without defined timelines or scientific justification, potentially compromising the integrity of data and the timely resolution of issues. JNTL Consumer Health is required to respond to these observations with a comprehensive plan of corrective and preventive actions to ensure compliance with regulatory standards for control testing laboratories.