# FDA 483 - Roy F. Chemaly - March 03, 2021

Source: https://www.keypedia.com/records/483/roy-f-chemaly/6fac534a-ae9e-4f0a-8efe-6f01e4781596

> FDA 483 for Roy F. Chemaly on March 03, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Roy F. Chemaly
- Inspection Date: 2021-03-03
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Roy F. Chemaly, a clinical investigator in Houston, TX, revealed a significant compliance issue related to clinical trial conduct. The firm failed to report serious adverse events (SAEs) to the study sponsor within the timeframes specified by the study protocols. This indicates a critical lapse in patient safety reporting and adherence to regulatory requirements for investigational drug studies.

## Related Officers

- [investigator](https://www.keypedia.com/people/zerita-white/82b19f0c-bd17-4a44-8523-8986f38851a8)

Company: https://www.keypedia.com/companies/roy-f-chemaly/64593ffc-4ed7-4c6b-8244-4f09fdb33763

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