Lupin LimitedAugust 16, 2022

FDA 483 - Lupin Limited - August 16, 2022

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Record Details

Lupin Limited, an API/Intermediate manufacturer in Ankleshwar, Gujarat, India, was inspected by the FDA from August 16-19, 2022. The inspection revealed significant deficiencies in batch production records, indicating a lack of complete information regarding manufacturing calculations, checklists, ingredient dispensing, yield determination, and rationale for ingredient usage. These issues suggest potential problems with data integrity and process control.

Company: Lupin Limited
Inspection Date: August 16, 2022
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Alan P. Kurtzberg (Consumer Safety Officer (Drug Specialist))

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ID · 2824070f-8472-4cbf-966a-43275ec641e5