# FDA 483 - Merrill K. Shum, M.D. - February 15, 2023

Source: https://www.keypedia.com/records/483/merrill-k-shum-md/064ce2bd-061f-4fc7-a200-a8c2fbc5615e

> FDA 483 for Merrill K. Shum, M.D. on February 15, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Merrill K. Shum, M.D.
- Inspection Date: 2023-02-15
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Merrill K. Shum, M.D., a clinical investigator in Whittier, CA, was inspected by the FDA from January 25 to February 15, 2023. The inspection revealed a significant deficiency related to the failure to report serious adverse events to the sponsor within 24 hours of awareness for multiple subjects. This indicates a serious lapse in compliance with clinical trial reporting requirements.

## Related Officers

- [investigator](https://www.keypedia.com/people/cheron-m-portee/c2cf139d-e4ce-400d-893e-bd733b3ec3a9)

Company: https://www.keypedia.com/companies/merrill-k-shum-md/fdc2a895-e0a0-4d96-82ec-f07d1485a9d3

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