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Regulatory Update:
U.S. FDA Warning Letter and Our Commitment to Quality

Vedic Lifesciences is committed to maintaining the highest standards of scientific integrity, quality and regulatory compliance across all services provided to our sponsors.

As part of our commitment to transparency, we wish to provide an update regarding the U.S. Food and Drug Administration (FDA) Warning Letter dated 6 March 2026 and observations arising from the FDA Bioresearch Monitoring (BIMO) inspection of our nonclinical GLP operations affiliated with two of our vendors.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/vedic-lifesciences-pvt-ltd-722446-03092026

The following information is provided to offer appropriate context regarding the matter.

Vedic Lifesciences is committed to maintaining the highest standards of scientific integrity, quality and regulatory compliance across all services provided to our sponsors.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/vedic-lifesciences-pvt-ltd-722446-03092026

The following information is provided to offer appropriate context regarding the matter.

Scope of the FDA
Warning Letter

The FDA Warning Letter relates exclusively to observations arising identified from a Bioresearch Monitoring (BIMO) inspection of certain nonclinical GLP studies performed under 21 CFR Part 58. The observations were related to legacy nonclinical studies conducted prior to 2018 by third party- labs one of which is no longer operational. The Warning Letter did not relate to, involve or question the conduct, oversight or data integrity of Vedic Lifesciences' clinical (human) research activities. Our clinical research operations have always functioned under separate operational processes, governance and quality oversight, and were not the subject of the FDA inspection or the resulting observations.

Background

The nonclinical studies referenced in the Warning Letter were conducted through two external test facilities one of which subsequently ceased operations following a change in the strategic priorities of its owners. As the external facility is no longer operational, certain study-specific corrective actions involving the original test facility are no longer feasible. However, Vedic Lifesciences has implemented comprehensive systemic corrective and preventive actions within its own Quality Management System to address the underlying process improvements identified during the review.

Process Improvements

Vedic Lifesciences had reviewed its nonclinical GLP processes in year 2022 and implemented comprehensive procedural improvements including for vendor qualifications to ensure alignment with current GLP regulations governing non-clinical studies.

Key improvements include:

Revision of applicable Standard Operating Procedures (SOPs).

Enhanced qualification, monitoring and quality oversight of third-party GLP laboratory partners.

Vedic has also recently taken additional steps with the Integration of the independent regulatory consultancy REJIMUS, Inc. to provide ongoing regulatory guidance and oversight of all Vedic GLP operations for all its studies and clientele.

Establishment of Quality Agreements between Vedic Lifesciences and all third-party vendors

Revised documentation practices to ensure that final GLP study reports are issued by the responsible Study Director of the performing test facility, consistent with applicable GLP requirements.

Routine quality audits before study initiation and during study conduct.

Transparency with Sponsors

Since implementation of these process improvements, Vedic Lifesciences has maintained full transparency with sponsors regarding the use of qualified partner GLP test facilities. GLP facilities issue the final GLP study report, while Vedic Lifesciences continues to provide scientific coordination, project management and quality oversight throughout the study lifecycle.

Current Regulatory Status

Vedic Lifesciences submitted a comprehensive written response to the U.S. FDA on 30 March 2026. The Agency acknowledged receipt of our response. While we are currently awaiting completion of the Agency's review and any further agency communication we have engaged with REJIMUS, Inc., an independent US based regulatory consultancy to provide overall strategic regulatory guidance and support for our operations as needed, future study planning, and other regulatory compliance matters as they arise.

This page will be updated as appropriate when additional regulatory information becomes available.

Commitment to Quality

The observations described in the Warning Letter relate to historical practices that have since been addressed through procedural improvements implemented in 2022.

Vedic Lifesciences remains committed to:

The observations described in the Warning Letter relate to historical practices that have since been addressed through procedural improvements implemented in 2022.

Vedic Lifesciences remains committed to:

Maintaining compliance with all current applicable regulatory requirements.

Ensuring the integrity, quality and reliability of studies conducted on behalf of our sponsors at the present moment and moving forward.

Continuous improvement of our Quality Management System.

Scientific integrity and ethical research practices.

Scientific integrity and ethical research

practices.

Robust quality oversight throughout the study lifecycle.

Transparency with sponsors and regulatory authorities.

Transparency with sponsors and regulatory

authorities.

Quality remains fundamental to every study undertaken by Vedic Lifesciences, and we continue to strengthen our systems through ongoing process review, personnel training and quality oversight.

Contact Us

Should you require additional information regarding this regulatory update or wish to discuss our Quality Management System, we would be pleased to arrange a meeting at your convenience.

Important Regulatory Notice

This communication is provided to summarize the current status of the matter.

It should not be interpreted as representing the views or conclusions of the U.S. FDA regarding Vedic Lifesciences' response, which remains under Agency review.