# FDA 483 - Helen K. Chew, M.D. - March 10, 2021

Source: https://www.keypedia.com/records/483/helen-k-chew-md/c3951012-ff89-40df-b92b-296a4b1a3e7a

> FDA 483 for Helen K. Chew, M.D. on March 10, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Helen K. Chew, M.D.
- Inspection Date: 2021-03-10
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Helen K. Chew, M.D., a clinical investigator in Sacramento, CA, was cited for significant deficiencies in the conduct of clinical investigations. Observations included failures to follow investigational plans, collect required safety data, report protocol deviations to the IRB, maintain accurate case histories, and promptly report adverse events to the sponsor. Additionally, the firm failed to obtain proper informed consent from a human subject before conducting a study-related test.

## Related Officers

- [investigator](https://www.keypedia.com/people/dustin-r-abaonza/0a9994bd-d6ab-47cc-8f1b-5bf4d10bd852)

Company: https://www.keypedia.com/companies/helen-k-chew-md/6ae76f5b-0165-427e-9ed2-d5391f0149bd

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