# FDA 483 - Parag Kalyani, M.D. - July 01, 2024

Source: https://www.globalkeysolutions.net/records/483/parag-kalyani-md/44f92f7e-8c78-4f6e-9fc0-3e32c121cfa6

> FDA 483 for Parag Kalyani, M.D. on July 01, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Parag Kalyani, M.D.
- Inspection Date: 2024-07-01
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Parag Kalyani, MBBS, MD, Clinical Investigator in Pune, India, identified significant failures in conducting a bioequivalence/bioavailability clinical study according to Good Clinical Practices. The inspection revealed widespread issues including inadequate case histories, numerous data discrepancies, missing and manipulated study documentation, and insufficient adverse event reporting. These findings raise serious concerns about the integrity and reliability of the clinical trial data.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/courtney-n-long/32118415-bc77-4ac2-8f90-947e43cf10ff)

Company: https://www.globalkeysolutions.net/companies/parag-kalyani-md/20ed8d5d-e15d-4a53-809a-aa579f662f37

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