# FDA 483 - Namita A. Goyal, M.D. - June 23, 2023

Source: https://www.keypedia.com/records/483/namita-a-goyal-md/e7e5de0d-a580-41b5-a6c4-0fb7c7552ce3

> FDA 483 for Namita A. Goyal, M.D. on June 23, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Namita A. Goyal, M.D.
- Inspection Date: 2023-06-23
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Namita A. Goyal, M.D. in Orange, CA, revealed multiple significant deficiencies in the conduct of clinical trials. The firm failed to adhere to the signed investigator statement, obtain legally effective informed consent, and promptly report serious adverse events. Additionally, the inspection found issues with obtaining IRB approval for research changes and maintaining adequate and accurate case histories.

## Related Officers

- [Theressa B. Smith](https://www.keypedia.com/people/theressa-b-smith/80f0c339-7eac-4c73-b9f6-ecb368738fe6)

Company: https://www.keypedia.com/companies/namita-a-goyal-md/60b02d24-42cd-40c3-b9e7-ea2eefeff103

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