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

An FDA inspection of Shiva Analyticals (India) Pvt. Ltd., a contract testing laboratory in Hoskote Bangaluru, revealed significant deficiencies across its quality control unit. Observations included widespread data integrity issues, inadequate analytical method validation, and a failure to thoroughly investigate discrepancies and customer complaints. These findings indicate a severe lack of oversight and adherence to cGMP principles.