483
Lupin Limited (Unit II)Lupin Limited (Unit II) – FDA 483, Dec 4, 2018
Record Details
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.
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ID · 01157280-eaec-44ff-b43a-16ebb2d2c1c2
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