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

JNTL Consumer Health (India) Private Limited, a control testing laboratory in Mumbai, India, received a Form 483 with two observations. The inspection revealed deficiencies in the routine inspection and impact assessment of electronic equipment, leading to unexplained failures and potential data loss. Additionally, the facility failed to justify deviations from written laboratory mechanisms, specifically regarding its preventative maintenance program and the timely closure of investigations and corrective actions.