# FDA 483 - Robert Hayashi M.D - July 08, 2022

Source: https://www.globalkeysolutions.net/records/483/robert-hayashi-md/e6795bc6-721c-43c0-b4f5-d5a4270a1235

> FDA 483 for Robert Hayashi M.D on July 08, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Robert Hayashi M.D
- Inspection Date: 2022-07-08
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Robert Hayashi M.D., a clinical investigator at Washington University School of Medicine in Saint Louis, MO, revealed significant deviations from an investigational plan. The inspection found failures to adhere to protocol requirements, including the omission of specific treatments for a pediatric subject and the administration of investigational product to an ineligible subject. These findings indicate a lack of adherence to clinical trial protocols.

## Related Officers

- [Carmen Y. Fisher](https://www.globalkeysolutions.net/people/carmen-y-fisher/d41b9f1a-1a29-4b1c-bd64-acedde50302a)

Company: https://www.globalkeysolutions.net/companies/robert-hayashi-md/d086cfb8-b6fd-4ae5-be14-e381f7f84a4b

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8