SUN PHARMACEUTICAL INDUSTRIES INC – FDA 483, Jul 24, 2026

SUN PHARMACEUTICAL INDUSTRIES INC was cited for significant failures in conducting clinical investigations according to protocol and for inadequate monitoring. The firm failed to ensure required Hepatitis B core antibody testing for subject eligibility was performed, impacting 93 subjects across two studies. Additionally, systemic deficiencies were noted in the sponsor's monitoring program, which failed to promptly identify and correct investigator non-compliance and ensure adequate completion of protocol-required questionnaires.