# FDA 483 - Drissana T. Tran, MD - October 11, 2024

Source: https://www.keypedia.com/records/483/drissana-t-tran-md/e328041b-5a6a-4d67-8507-aca934209f09

> FDA 483 for Drissana T. Tran, MD on October 11, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Drissana T. Tran, MD
- Inspection Date: 2024-10-11
- Product Type: drugs
- Office Name: Seattle District Office
- Summary: An FDA inspection of Drissana T. Tran, MD, a clinical investigator operating at Salem Free Clinic in Salem, OR, revealed a significant failure in maintaining adequate and accurate case histories for a human clinical study under an IND. Specifically, the investigator failed to document assessments of adverse event relatedness to the study drug for numerous adverse events experienced by all 19 subjects. This indicates a serious lapse in record-keeping for clinical trial data.

## Related Officers

- [investigator](https://www.keypedia.com/people/sherri-n-rohlf/41090ab1-83d1-4e95-92ea-0cfca5cecdb6)

Company: https://www.keypedia.com/companies/drissana-t-tran-md/1e1ea404-b4ae-4f4e-82cd-ea68294c4cb3

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913