# FDA 483 - Mukesh B. Chandre, MD MBBS - May 09, 2025

Source: https://www.keypedia.com/records/483/mukesh-b-chandre-md-mbbs/cbf39d53-fbac-4330-8065-a717641c88eb

> FDA 483 for Mukesh B. Chandre, MD MBBS on May 09, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mukesh B. Chandre, MD MBBS
- Inspection Date: 2025-05-09
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Mukesh B. Chandre, MD MBBS, a clinical investigator in Nashik, Maharashtra, India, revealed two significant observations. The firm failed to maintain accurate case histories, specifically regarding discrepancies in signing investigational product preparation worksheets. Additionally, the firm failed to conduct a foreign clinical study in accordance with Good Clinical Practices, as the informed consent document contained unproven claims about the investigational product's effectiveness.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/koffi-a-amegadje/817a228e-0003-43d0-bf59-71aeba0fd1f5)

Company: https://www.keypedia.com/companies/mukesh-b-chandre-md-mbbs/dfd42a72-cdbe-4c32-8d5c-0905ba488bdb

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