FDA 483 - Lupin Limited - August 16, 2022

Lupin Limited, an API/Intermediate manufacturer in Ankleshwar, Gujarat, India, was inspected by the FDA from August 16-19, 2022. The inspection revealed significant deficiencies in batch production records, indicating a lack of complete information regarding manufacturing calculations, checklists, ingredient dispensing, yield determination, and rationale for ingredient usage. These issues suggest potential problems with data integrity and process control.