# FDA 483 - Shammo, Jamile, MD - August 26, 2005

Source: https://www.keypedia.com/records/483/shammo-jamile-md/426be67c-89a8-4aa5-b2af-f8e12b07438c

> FDA 483 for Shammo, Jamile, MD on August 26, 2005. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shammo, Jamile, MD
- Inspection Date: 2005-08-26
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of Jamile Shammo, MD, a clinical investigator in Chicago, IL, revealed significant deficiencies in the conduct of a clinical investigation. Observations included widespread failure to adhere to the study protocol and investigator statement, delayed reporting of serious adverse events to the sponsor and IRB, and a failure to obtain legally effective informed consent from multiple subjects. These issues indicate serious non-compliance with regulations governing human subject protection and clinical trial conduct.

## Related Officers

- [Kujtim Sadiku](https://www.keypedia.com/people/kujtim-sadiku/a099cc59-f871-4396-9af5-d4d9fbd5d83a)

Company: https://www.keypedia.com/companies/shammo-jamile-md/f6a6f898-9bcb-4442-b136-740039bd7c98

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669