FDA 483 - Vedic Lifesciences Pvt Ltd - January 15, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 891ce37c-807b-4048-b758-4c76aae14d01