# FDA 483 - James K. Luu, MD - December 18, 2020

Source: https://www.keypedia.com/records/483/james-k-luu-md/45b050d3-70f7-452f-9090-85861ec31ecb

> FDA 483 for James K. Luu, MD on December 18, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: James K. Luu, MD
- Inspection Date: 2020-12-18
- Product Type: drugs
- Office Name: Denver District Office
- Summary: James K. Luu, MD, a clinical investigator in Colorado Springs, CO, was cited for failing to conduct an investigation in accordance with the investigational plan. The inspection revealed that Dr. Luu, as Principal Investigator, did not provide adequate oversight of study personnel. This led to primary endpoint measurements being conducted by non-certified personnel, a direct violation of the study protocol's certification requirements.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/ruth-a-williams/f6dd5e30-fe9a-4b18-9703-dc471a55f24f)

Company: https://www.keypedia.com/companies/james-k-luu-md/86a2c1be-5f73-45d7-9e19-f5d4aea7f4db

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face