FDA 483 - Lupin Ltd. - March 06, 2024

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.