Lupin Limited (Biotech Division)October 14, 2022

FDA 483 - Lupin Limited (Biotech Division) - October 14, 2022

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Record Details

Lupin Limited (Biotech Division) in Pune, India, was inspected by the FDA from October 3-14, 2022, and received 18 observations. The inspection revealed significant deficiencies in aseptic processing, environmental monitoring, quality control, and facility maintenance for drug substance and drug product manufacturing. These issues indicate a lack of adequate controls to prevent contamination and ensure product quality and purity.

Company: Lupin Limited (Biotech Division)
Inspection Date: October 14, 2022
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Li Yongmin (company_representative)
Yan Wang (recipient)
Cynthia Jim
Wayne E. Seifert (Senior Regulatory Specialist)

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