FDA 483 - Elysium Pharmaceuticals Limited - January 16, 2023

An FDA inspection of Elysium Pharmaceuticals Limited in Vadodara, India, revealed significant deficiencies across laboratory controls, facility maintenance, and production record-keeping. Observations included unrecorded deviations from test procedures, incomplete laboratory data, water system leaks, inadequate equipment cleaning, and missing documentation of personnel actions in batch records. These issues indicate a lack of adherence to good manufacturing practices.