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

An FDA Form 483 was issued to a nonclinical laboratory in Andheri West Mumbai, Maharashtra, India, following an inspection conducted from January 13 to January 15, 2025. The observations highlight significant deficiencies in the conduct and reporting of nonclinical studies, indicating a departure from Good Laboratory Practices. Key issues identified across several studies include an unsuitable test facility that was not appropriately sized or constructed to ensure study validity. Facility management failed to ensure study plans were approved by the designated Study Director and did not maintain a complete master schedule. Furthermore, the identified Study Director did not consistently function as the single point of control responsible for overall study conduct and final reports. Additional concerns involved the quality of study documentation: final reports lacked required Quality Assurance statements, omitted the Study Director's name and address in one instance, and contained inaccurate information regarding GLP compliance, personnel, test facility details, and archive locations. Critically, fundamental analyses, such as determining the homogeneity, concentration, and stability of test items in their vehicles, were not performed for several studies. These observations, issued under Section 704(b) of the Federal Food, Drug, and Cosmetic Act, require the Chief Executive Officer, Jayesh Chaudhary, to promptly address the identified shortcomings. The company is expected to implement comprehensive corrective actions to ensure future compliance with regulatory standards for nonclinical laboratory studies.