FDA 483 - Lupin Ltd. - March 15, 2024

The U.S. Food and Drug Administration (FDA) conducted an inspection of Lupin Ltd.'s human drug manufacturing facility in Aurangabad, Maharashtra, India, from March 6 to March 15, 2024. This inspection resulted in the issuance of a Form FDA 483, highlighting a significant observation related to the company's production and process controls. The primary issue identified was Lupin Ltd.'s failure to establish written procedures to ensure drug product identity, strength, purity, and quality. Specifically, the company had not performed process validation for a newly installed sanitation method within its Block (b) (4) system. This system is critical as its output serves as an ingredient in drug products destined for the U.S. market, including (b) (4) Capsules USP and (b) (4) Suspension. Additionally, since the implementation of this new sanitation process, the sampling of production user ports has been insufficient, occurring only once. This observation indicates a deficiency in upholding current Good Manufacturing Practice principles, particularly regarding process validation and ongoing quality control for critical manufacturing steps. Lupin Ltd. is required to address this observation by providing a formal response outlining its proposed corrective and preventive actions to ensure compliance.