FDA 483 - Lupin Limited (Unit II) - December 04, 2018

An FDA inspection of Lupin Limited (Unit II) in Mandideep, India, revealed significant deficiencies in manufacturing practices. The firm was cited for inadequate cleaning validation processes for equipment, insufficient performance qualification of water treatment systems, and a lack of proper Quality Unit oversight. Additionally, the inspection found that user access controls for computerized SCADA systems were not adequately defined.