# FDA 483 - Nader Iskander, M.D. - August 06, 2021

Source: https://www.globalkeysolutions.net/records/483/nader-iskander-md/e52e30e3-33fa-40f5-8ce1-49466ca41591

> FDA 483 for Nader Iskander, M.D. on August 06, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nader Iskander, M.D.
- Inspection Date: 2021-08-06
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Nader Iskander, M.D., a clinical investigator in San Antonio, TX, was cited for two significant observations during an FDA inspection. The firm failed to conduct an investigation in accordance with the signed statement of investigator and investigational plan, including issues with subject eligibility and measurement scales. Additionally, the firm failed to obtain informed consent from human subjects using the most current IRB-approved version prior to drug administration and study-related tests.

## Related Documents

- [EIR - 2021-08-06](https://www.globalkeysolutions.net/records/eir/nader-iskander-md/9c2301d9-f54b-4504-a75c-293ef68832da)

## Related Officers

- [Iris C. Macinnes](https://www.globalkeysolutions.net/people/iris-c-macinnes/5e8d7fef-18d5-453d-82b2-19e8e2897d26)

Company: https://www.globalkeysolutions.net/companies/nader-iskander-md/eee08ed9-50a8-4aa8-9707-46dcd2874834

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