# FDA 483 - Shahrukh A. Kureishy, MD - May 09, 2022

Source: https://www.globalkeysolutions.net/records/483/shahrukh-a-kureishy-md/75373b31-6486-4710-b534-a198327c5592

> FDA 483 for Shahrukh A. Kureishy, MD on May 09, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shahrukh A. Kureishy, MD
- Inspection Date: 2022-05-09
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Shahrukh A. Kureishy, MD, a clinical investigator in McKinney, TX, revealed a significant deviation from an investigational plan. A study subject who met withdrawal criteria due to hospitalization was not withdrawn and continued to receive the test article. This indicates a failure to adhere to study protocol and proper subject management.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/shahrukh-a-kureishy-md/5a1e7d4e-2c47-4051-9af8-bdba6c8a391b

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab