# FDA 483 - Issam Makhoul - September 08, 2025

Source: https://www.keypedia.com/records/483/issam-makhoul/aedb86ad-a45f-478e-b4a4-94f095af4caa

> FDA 483 for Issam Makhoul on September 08, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Issam Makhoul
- Inspection Date: 2025-09-08
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of clinical investigator Issam Makhoul in Little Rock, AR, revealed a significant deviation from the investigational plan. The firm failed to ensure that all subjects met eligibility criteria before randomization into a study. Specifically, subjects using prohibited medications were randomized, compromising the integrity of the clinical trial.

## Related Officers

- [Terri E. Gibson](https://www.keypedia.com/people/terri-e-gibson/f1a80f95-a5c4-4cae-9a4b-e23f367770bb)

Company: https://www.keypedia.com/companies/issam-makhoul/87b0e8d7-a9cd-4fbf-8177-44e4a7fcc06d

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