# FDA 483 - Wakai, Ronald, Ph. D., Clinical Investigator - August 22, 2014

Source: https://www.globalkeysolutions.net/records/483/wakai-ronald-ph-d-clinical-investigator/a2e4d45c-2f03-4fc4-a1bc-58ccd9d6c59f

> FDA 483 for Wakai, Ronald, Ph. D., Clinical Investigator on August 22, 2014. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wakai, Ronald, Ph. D., Clinical Investigator
- Inspection Date: 2014-08-22
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Ronald Wakai, Ph. D., Clinical Investigator, was inspected regarding an investigational device study. The inspection revealed significant deficiencies in study conduct, monitoring, record-keeping, and informed consent processes. These issues indicate a lack of adherence to the investigational plan, signed agreements, and applicable FDA regulations, impacting subject safety and data integrity.

## Related Documents

- [WARNING_LETTER - 2014-08-22](https://www.globalkeysolutions.net/records/warning_letter/wakai-ronald-ph-d-clinical-investigator/4eb0e58e-dec5-470d-95c7-a2bc76f2ee99)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/corey-k-reno/f6ff7629-784b-467b-8b5b-2625779d1c1e)

Company: https://www.globalkeysolutions.net/companies/wakai-ronald-ph-d-clinical-investigator/e30a9be0-c9ea-4c33-9d78-80d9c33174ea

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d