# FDA 483 - Savita Rangarajan, MD, MBBS, FRCPath - September 27, 2024

Source: https://www.keypedia.com/records/483/savita-rangarajan-md-mbbs-frcpath/0a6881ee-ee08-4922-99b0-d7072cbf2323

> FDA 483 for Savita Rangarajan, MD, MBBS, FRCPath on September 27, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Savita Rangarajan, MD, MBBS, FRCPath
- Inspection Date: 2024-09-27
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of KJ Somaiya Hospital and Research Centre in Mumbai, India, revealed significant issues with maintaining accurate case histories for investigational drug studies. The site failed to reconcile the timing of investigational product administration with the vendor-supplied interactive response technology (IRT) system. These discrepancies, observed across three reviewed studies, indicate potential data integrity concerns in clinical trial documentation.

## Related Officers

- [Bioresearch Monitoring Foreign Inspection Cadre Member](https://www.keypedia.com/people/richard-w-berning/4637e321-8803-4fcf-911f-bbc810c3487d)

Company: https://www.keypedia.com/companies/savita-rangarajan-md-mbbs-frcpath/a4f885e1-f43c-48c5-b0dc-71d788ca863c

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