FDA 483 - Shiva Analyticals (India) Pvt. Ltd. - January 24, 2025

The FDA inspection of Shiva Analyticals (India) Pvt. Ltd. in Hoskote Bangaluru revealed significant deficiencies across its quality control and assurance units. The firm failed to maintain data integrity, lacked scientifically sound analytical test procedures, and conducted inadequate investigations into laboratory discrepancies and customer complaints. These issues indicate a severe breakdown in the firm's overall quality systems.