FDA 483 - SRI Krishna Pharmaceuticals Ltd - Unit I - April 18, 2025

Sri Krishna Pharmaceuticals Limited Unit I in Hyderabad, Telangana, was cited for significant deficiencies across its API manufacturing operations. The inspection revealed widespread issues with facility and equipment maintenance, inadequate contamination control during product handling, and a systemic failure in conducting comprehensive investigations into quality events and implementing effective corrective and preventive actions. Additionally, the quality control unit demonstrated deficient oversight of laboratory electronic systems and data integrity, and cleaning procedures were found to be inadequate.