The U.S. FDA has completed a product-specific pre-approval inspection of Lupin’s Pune Biotech facility. The inspection, which occurred between September 8 and September 19, 2025, concluded with four observations. Lupin is committed to addressing the observations and responding to the FDA within the stipulated timeframe. The company aims to remain compliant with CGMP quality standards across all its facilities.
FDA Inspection Concluded
Lupin has announced the completion of a product-specific Pre-Approval Inspection by the U.S. Food and Drug Administration (FDA) at its Pune Biotech facility. The inspection took place from September 08 to September 19, 2025.
Key Details and Next Steps
According to the company’s statement, the inspection concluded with four observations. Lupin has committed to addressing these observations and responding to the U.S. FDA within the specified timeframe. The company reaffirms its commitment to maintaining compliance with current Good Manufacturing Practice (CGMP) quality standards across all of its facilities.
Source: BSE
