# FDA 483 - Sukit Christopher Malaisrie, M.D. - September 04, 2019

Source: https://www.keypedia.com/records/483/sukit-christopher-malaisrie-md/c4806bb5-eac8-4c60-997d-e3b3979ab4ff

> FDA 483 for Sukit Christopher Malaisrie, M.D. on September 04, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sukit Christopher Malaisrie, M.D.
- Inspection Date: 2019-09-04
- Product Type: other
- Office Name: Chicago District Office
- Summary: Dr. Sukit Christopher Malaisrie, a Clinical Investigator in Chicago, IL, was inspected by the FDA from August 19 to September 4, 2019. The inspection revealed two significant issues related to the protection of human subjects and investigational device studies. Specifically, deficiencies were noted in obtaining informed consent prior to an investigational device implant and in the timely reporting of an unanticipated adverse device effect to the Institutional Review Board (IRB).

## Related Officers

- [investigator](https://www.keypedia.com/people/jeanne-j-thai/f7b057a4-ab4c-43de-a448-384ff9f8598f)

Company: https://www.keypedia.com/companies/sukit-christopher-malaisrie-md/78854122-1f88-47e3-aa6e-c6b0c4df123e

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