# FDA 483 - Rajinder S. Shiwach, M.D. - June 11, 2025

Source: https://www.globalkeysolutions.net/records/483/rajinder-s-shiwach-md/bf794813-f214-49b3-a835-b8ffb75d0ee6

> FDA 483 for Rajinder S. Shiwach, M.D. on June 11, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rajinder S. Shiwach, M.D.
- Inspection Date: 2025-06-11
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Rajinder S. Shiwach, M.D. (Insite Clinical Research) in Desoto, TX, revealed significant deficiencies in clinical study conduct. Observations included failure to ensure proper IRB review and approval for a "guesting" process, as well as enrolling ineligible subjects and failing to discontinue treatment for subjects meeting discontinuation criteria. These findings indicate serious non-compliance with regulatory requirements for clinical investigations.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/travis-m-beard/a89f6d0b-dc5b-4adc-84f5-36e04b00fc2d)

Company: https://www.globalkeysolutions.net/companies/rajinder-s-shiwach-md/1c35f8c6-ef47-4802-b976-011300458fec

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9