Lupin Ltd.September 5, 2025

FDA 483 - Lupin Ltd. - September 05, 2025

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Record Details

An FDA inspection of Lupin Ltd. in Aurangabad, Maharashtra, India, revealed two significant observations. The firm failed to properly qualify visual inspectors for finished drug capsule products, raising concerns about product quality assurance. Additionally, the company did not maintain adequate records for the cleaning of production equipment, specifically regarding cleaning chemical details.

Company: Lupin Ltd.
Inspection Date: September 5, 2025
Product Type: Drugs
Office: Office of Inspections and Investigations
Person: Christopher R. Czajka (Consumer Safety Officer (Inspector))

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ID · 326bcd40-7462-477d-9bd8-e0098e42215f