Lupin Ltd.March 6, 2024

FDA 483 - Lupin Ltd. - March 06, 2024

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Record Details

Lupin Ltd. in Aurangabad, Maharashtra, India, a human drug manufacturer, was inspected by the FDA from March 6-15, 2024. The inspection revealed a failure to establish adequate written procedures for production and process controls. Specifically, the firm did not perform process validation for a new sanitization method used in a critical water system, which impacts drug products for the US market.

Company: Lupin Ltd.
Inspection Date: March 6, 2024
Product Type: Drugs
Office: Center for Veterinary Medicine
People: Vaishali J. Patel
Lisa L. Flores (Consumer Safety Officer/ Federal Investigator)

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ID · 48e726de-aa36-4328-a07c-74dcddd776e0