FDA 483 - Sandoz Private Limited - January 22, 2024

Sandoz Private Limited in Hyderabad, India, received a Form 483 with three observations related to significant data integrity and quality system deficiencies. The firm failed to thoroughly investigate lost chromatographic data and lacked adequate oversight of GMP document management, including instances of document destruction. Additionally, the employee training program was found to be deficient, not ensuring employees' familiarity with CGMP requirements.