FDA 483 - BIONEEDS INDIA PRIVATE LIMITED - January 19, 2024

Bioneeds India Private Limited, a contract testing laboratory in Bangalore Rural, India, was cited for significant deficiencies in its laboratory control systems during an FDA inspection. Observations included inadequate evaluation of method validation deviations, insufficient procedures for investigating assay failures, and a failure to consistently follow validated test methods. These issues indicate a lack of robust quality control over drug substance and drug product testing.