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

Source: https://www.globalkeysolutions.net/records/483/vedic-lifesciences-pvt-ltd/891ce37c-807b-4048-b758-4c76aae14d01

> FDA 483 for Vedic Lifesciences Pvt Ltd on January 15, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Vedic Lifesciences Pvt Ltd
- Inspection Date: 2025-01-15
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/zhou-chen/03362438-eba1-4010-b6b1-5cccf25a824c)
- [issuing_officer](https://www.globalkeysolutions.net/people/mark-j-seaton/640c2deb-25ff-4e2e-8f48-d15d31f9c5bf)

Company: https://www.globalkeysolutions.net/companies/vedic-lifesciences-pvt-ltd/f75779ce-28a2-48f7-bb0a-e1c40e61b441

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8