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In a regulatory filing, the company said the EIR was issued following an inspection conducted by the US FDA at the Nagpur injectable facility from September 8 to September 16, 2025. Shares of Lupin Ltd ended at ₹2,085.90, down by ₹6.70, or 0.32%, on the BSE.
Pharma major Lupin Ltd on Tuesday (December 16) said it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its injectable facility located in Nagpur, India, with a satisfactory Voluntary Action Indicated (VAI) classification.
In a regulatory filing, the company said the EIR was issued following an inspection conducted by the US FDA at the Nagpur injectable facility from September 8 to September 16, 2025.
Nilesh Gupta, Managing Director, Lupin, said, “We are pleased to have received the EIR from the US FDA with a VAI classification for our Nagpur injectable facility. We are committed to upholding the highest standards of quality and compliance across our facilities, with continued focus on enhancements to our quality systems and operational excellence."
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What is an Establishment Inspection Report (EIR)?
Based on the inspection and the response given by the company to the USFDA, the FDA will release an Establishment Inspection Report (EIR) within 30 days of the inspection. The EIR reflects the FDA’s official determination of a factory’s GMP compliance.
The FDA and the Inspection Classification Database classify the inspection by each project area with one of three classifications. The three classifications displayed are:
No Action Indicated (NAI):- Given if no violations were observed. The facility can continue selling approved drugs and will also receive approvals for new filings.
Voluntary Action Indicated (VAI):- Given when violations are found, but the problems do not justify further regulatory action. Improving GMP compliance is voluntary in this case. The facility can continue selling approved drugs and will also receive approvals for new filings.
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Official Action Indicated (OAI):- Given that violations found on-site require further administrative sanctions and mandatory corrective actions.
Shares of Lupin Ltd ended at ₹2,085.90, down by ₹6.70, or 0.32%, on the BSE.
