Lupin Receives USFDA EIR With VAI Classification for Goa Facility

Lupin has announced that it has received an Establishment Inspection Report from the US Food and Drug Administration for its manufacturing facility in Goa. The inspection, which took place from November 10–21, 2025, has been classified as Voluntary Action Indicated.

This classification signifies that the regulator’s observations do not require any major corrective action. The company stated that the outcome reflects adherence to regulatory standards for its operations.

USFDA Inspection Details and VAI Classification

The USFDA conducted a detailed inspection of the Goa manufacturing site over an 11‑day period in November 2025. Following the completion of its review process, the regulator issued the EIR indicating a VAI classification for the facility.

A VAI outcome typically suggests that observations noted during inspection can be addressed voluntarily by the company. The issuance of the EIR marks the formal closure of the inspection process for the site.

Purpose Of an Establishment Inspection Report

An Establishment Inspection Report is issued by the USFDA at the conclusion of an inspection or regulatory assessment. It is used to communicate the regulator’s findings to the inspected establishment and summarises the compliance status for the facility.

An EIR also provides clarity on whether additional regulatory steps are required. In this case, the satisfactory VAI status confirms that no significant enforcement action is considered necessary.

Significance Of the Inspection Outcome for Lupin

Lupin stated that the favourable EIR outcome underscores its operational and quality-control efforts. The company noted that regulatory reviews of this nature are important for maintaining uninterrupted supply of medicines to global markets.

The Goa site plays a role in the firm’s international portfolio, making regulatory compliance critical for its operations. The EIR supports the company’s ongoing work in meeting global manufacturing requirements.

Statement From Lupin’s Management

Managing Director Nilesh Gupta acknowledged the inspection outcome through an official statement. He indicated that the result highlights the company’s continued emphasis on maintaining quality and regulatory discipline.

His statement noted the importance of these processes in ensuring safe and effective medicines for patients. The company reiterated that it remains committed to strengthening compliance frameworks across its facilities.

Read More: Lupin Gets US FDA Approval for Brivaracetam Oral Solution.

Conclusion

The USFDA’s issuance of a satisfactory VAI‑classified EIR for Lupin’s Goa facility concludes the inspection conducted in November 2025. The outcome reflects the facility’s adherence to regulatory expectations and supports its manufacturing continuity for global markets.

Lupin has highlighted the result as evidence of its commitment to quality standards. The EIR closes the inspection while confirming that no major regulatory actions are required at this stage.

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