FDA 483 - Vedic Lifesciences Pvt Ltd - January 15, 2025

An FDA inspection of Vedic Lifesciences Pvt. Ltd., a nonclinical laboratory in Mumbai, India, revealed significant deficiencies across multiple studies. Observations included an unsuitable test facility, lack of Study Director approval for study plans, incomplete master schedules, and inaccuracies in final study reports regarding GLP compliance, Quality Assurance statements, and Study Director information. Additionally, critical test item characteristics like homogeneity, concentration, and stability were not determined.