# FDA 483 - Elaine E. Tseng, M.D. - January 07, 2022

Source: https://www.keypedia.com/records/483/elaine-e-tseng-md/cdaf51fe-0aa2-4168-bbd3-df59ace8589c

> FDA 483 for Elaine E. Tseng, M.D. on January 07, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Elaine E. Tseng, M.D.
- Inspection Date: 2022-01-07
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Elaine E. Tseng, M.D. in San Francisco, CA, from January 4-7, 2022, identified a critical deficiency in the reporting of serious adverse events. The clinical investigator and study staff failed to report all serious adverse events (SAEs) to the sponsor within the timeframe required by the study protocol. Specifically, four out of 24 SAEs occurring at the study site were reported late.

## Related Officers

- [Linh Tu](https://www.keypedia.com/people/linh-tu/142c94dc-9538-4c52-9a5f-be27fc7c4f4b)
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Company: https://www.keypedia.com/companies/elaine-e-tseng-md/20bf4154-f04c-4937-a949-055d3be8fdf7

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b