FDA 483 - Vedic Lifesciences Pvt. Ltd.

An FDA inspection of Vedic Lifesciences Pvt. Ltd. in Mumbai, Maharashtra, India, conducted from January 13-15, 2025, identified significant deficiencies in their nonclinical laboratory operations. The observations, issued to CEO Jayesh Chaudhary, pertain to upholding the integrity and validity of scientific studies, aligning with Good Laboratory Practice (GLP) principles under the Federal Food, Drug, and Cosmetic Act.

Key violations across multiple studies (e.g., 170117-1/MT/PC, 170117/MT/PC, and 181205/MT/PC) included an unsuitable test facility environment and a failure to ensure study plans were approved by the Study Director. The company also failed to maintain a complete master schedule, and the designated Study Director did not consistently function as the single point of control for study conduct and final reporting. Final study reports were found to be inaccurate regarding GLP compliance, personnel identification, and facility details, and consistently lacked a Quality Assurance statement. Additionally, critical data concerning the homogeneity, concentration, and stability of test items were not determined.

Vedic Lifesciences Pvt. Ltd. is required to address these findings by implementing comprehensive corrective actions. These measures are essential to ensure full compliance with regulatory standards, prevent recurrence, and safeguard the reliability of their nonclinical research. The firm must communicate their planned or implemented corrective actions to the FDA.