# FDA 483 - Tran-Johnson, Tram K. - February 01, 2019

Source: https://www.keypedia.com/records/483/tran-johnson-tram-k/ca952b30-901d-4b54-839b-5a19437c030f

> FDA 483 for Tran-Johnson, Tram K. on February 01, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tran-Johnson, Tram K.
- Inspection Date: 2019-02-01
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Ryan-Johnson, Tram K., a clinical investigator in San Diego, revealed two significant observations. The firm failed to report adverse effects related to an investigational drug to the sponsor, including severe orthostatic hypotension, syncope, and worsening drowsiness. Additionally, the firm failed to maintain adequate case histories, specifically by not transcribing a subject's history of suicide ideation into study records.

## Related Officers

- [investigator](https://www.keypedia.com/people/marilyn-s-babu/681b6d89-afae-4a11-bed1-858792b172a6)
- [issuing_officer](https://www.keypedia.com/people/diane-c-van-leeuwen/98af0d70-2db1-4132-8193-fcccf8841960)
- [Li Chin](https://www.keypedia.com/people/li-chin/bc82b3d3-6416-4da2-9161-c8e0c8a09bac)

Company: https://www.keypedia.com/companies/tran-johnson-tram-k/16da73c1-72e8-4420-a409-9c9e7130b7f5

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6