Lupin LimitedMarch 2, 2026

FDA 483 - Lupin Limited - March 02, 2026

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Record Details

An FDA inspection of Lupin Limited, an API manufacturer in Ankleshwar, India, revealed significant deficiencies in laboratory operations and production controls. The firm failed to thoroughly investigate numerous analytical incidents and did not follow established procedures for root cause analysis. Additionally, master production and control records lacked clearly defined time limits for processing steps, leading to observed variability.

Company: Lupin Limited
Inspection Date: March 2, 2026
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
People: Geoffrey K. Kilili (investigator)
Lisa L. Flores (Consumer Safety Officer/ Federal Investigator)

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