# FDA 483 - Balamurali K. Ambati , M.D., Ph.D. - April 04, 2019

Source: https://www.keypedia.com/records/483/balamurali-k-ambati-md-phd/5e6088ad-c61f-4254-805a-3c4412368071

> FDA 483 for Balamurali K. Ambati , M.D., Ph.D. on April 04, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Balamurali K. Ambati , M.D., Ph.D.
- Inspection Date: 2019-04-04
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Balamurali K. Ambati, M.D., Ph.D, MBA, Clinical Investigator in Eugene, OR, revealed a critical failure to submit an Investigational New Drug (IND) application. This omission occurred prior to conducting a clinical investigation involving an unapproved combination product. The study, which began in April 2017 and is ongoing, proceeded without the required FDA authorization, posing a significant regulatory non-compliance issue.

## Related Documents

- [WARNING_LETTER - 2019-04-04](https://www.keypedia.com/records/warning_letter/balamurali-k-ambati-md-phd/380cc958-be30-43ee-8573-0ae5efb9001c)

## Related Officers

- [Julian C. Hanson](https://www.keypedia.com/people/julian-c-hanson/489e27d9-0de6-4bf0-8aec-e5d500841f52)

Company: https://www.keypedia.com/companies/balamurali-k-ambati-md-phd/a6167b4b-86cb-400e-9cf2-39d29f4bffd7

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822