# FDA 483 - Ismail H. Mitha, M.D. - September 22, 2016

Source: https://www.globalkeysolutions.net/records/483/ismail-h-mitha-md/a651eb3a-9e12-4b4c-aa79-f07c32d9e905

> FDA 483 for Ismail H. Mitha, M.D. on September 22, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ismail H. Mitha, M.D.
- Inspection Date: 2016-09-22
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: Dr. Ismail H. Mitha, a clinical investigator in Benoni, South Africa, was cited for failing to conduct an investigation in accordance with the signed statement of investigator and investigational plan. An unblinded investigator improperly evaluated subjects and their clinical responses during a study, which was contrary to the protocol's blinding requirements. This represents a significant deviation from the established clinical trial protocol.

## Related Documents

- [483 - 2013-02-22](https://www.globalkeysolutions.net/records/483/ismail-h-mitha-md/ef799055-ccd7-4171-8131-a13cd07ede7b)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/marion-w-nadeau/84231ede-7569-4998-b22e-27119116dc03)

Company: https://www.globalkeysolutions.net/companies/ismail-h-mitha-md/e7268880-b76e-4683-b9cb-d8fa0e8fe4cb

Office: https://www.globalkeysolutions.net/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4