483
Lupin LimitedLupin Limited – FDA 483, Jul 17, 2025
Record Details
An FDA inspection of Lupin Limited, a human drug manufacturer in Pithampur, India, revealed significant deficiencies in quality control. The firm failed to adequately test components, thoroughly investigate customer complaints regarding product defects, and establish proper written procedures for in-process controls and electronic data review. These issues indicate a lack of robust quality management systems.
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ID · 6f335fb2-3d0d-4d12-baba-38bdf30583a1
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