Lupin LimitedJuly 17, 2025

FDA 483 - Lupin Limited - July 17, 2025

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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.

Company: Lupin Limited
Inspection Date: July 17, 2025
Product Type: Drugs
Office: Office of Inspections and Investigations
People: RafaeQ A Habash
Rafeeq A. Habeeb (Investigator)
Lisa L. Flores (Consumer Safety Officer/ Federal Investigator)

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ID · 6f335fb2-3d0d-4d12-baba-38bdf30583a1