FDA 483 - Sri Krishna Pharmaceuticals Limited - May 19, 2023

Sri Krishna Pharmaceuticals Ltd. - Unit 2, an Indian drug manufacturer, was cited for significant deficiencies across its quality system during an FDA inspection. The observations highlight a systemic failure in thoroughly investigating discrepancies, inadequate process controls, poor equipment cleaning, facility maintenance issues, and critical lapses in document control, data integrity, and complaint handling. These issues indicate a severe lack of oversight and adherence to GMP regulations.