The U.S. FDA concluded an inspection at Lupin’s manufacturing facility located in Goa, India on November 21, 2025. The inspection, which began on November 10, 2025, resulted in the issuance of a Form-483 with seven observations. Lupin has stated its commitment to addressing these observations within the stipulated timeframe and ensuring compliance with CGMP standards across its facilities.
FDA Inspection Update
Lupin has announced the completion of an inspection by the United States Food and Drug Administration (FDA) at its manufacturing facility in Goa, India. The inspection took place between November 10 and November 21, 2025.
Key Findings
At the conclusion of the inspection, the U.S. FDA issued a Form-483, which included seven observations. Lupin is currently reviewing these observations.
Company Commitment
Lupin has committed to addressing the observations raised by the U.S. FDA and will respond within the required timeframe. The company emphasizes its dedication to maintaining compliance with Current Good Manufacturing Practice (CGMP) standards across all its manufacturing sites. Further updates will be provided as the situation evolves.
Source: BSE