Lupin facility receives "official action indicated" status from US FDA
Lupin Limited informed the National Stock Exchange of India and BSE Limited on October 4, 2025, about the U.S. FDA's inspection classification of its Pithampur Unit-2 manufacturing facility. The inspection, conducted from July 8 to July 17, 2025, resulted in the issuance of a Form-483 with four observations.
The U.S. FDA has since determined the inspection classification for this facility as "Official Action Indicated (OAI)". Lupin is actively working with the U.S. FDA to resolve these compliance issues and has reiterated its commitment to maintaining CGMP standards across all its manufacturing facilities.
This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com
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