FDA WARNING_LETTER - Vedic Lifesciences Pvt. Ltd. - January 15, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Vedic Lifesciences Pvt. Ltd. on March 9, 2026, following an inspection from January 13 to 15, 2025. The inspection evaluated Vedic"s role as a testing facility for nonclinical laboratory studies of an investigational drug, under the regulatory framework of 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies. The main violations centered on Vedic"s failure to prepare accurate and complete final reports for outsourced studies. Specifically, Vedic misrepresented itself as the testing facility, falsely listed its personnel as study directors or Quality Assurance Unit members, and provided incorrect storage locations for study materials. The FDA noted that Vedic personnel signing reports were not involved in the studies, invalidating the signatures. While Vedic acknowledged outsourcing and outlined corrective actions, the FDA deemed its response inadequate, citing a lack of sufficient detail on new procedures, personnel training, and a comprehensive plan to ensure future compliance and data integrity. Vedic is required to submit a detailed written response within 15 business days, outlining concrete actions to prevent similar violations, addressing the FDA"s concerns regarding the validity and integrity of submitted study data.