# FDA 483 - Andre Kalil, M.D. - January 14, 2022

Source: https://www.globalkeysolutions.net/records/483/andre-kalil-md/7bf08e2b-f585-4584-8ed6-665ac26e0c25

> FDA 483 for Andre Kalil, M.D. on January 14, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Andre Kalil, M.D.
- Inspection Date: 2022-01-14
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Andre C. Kalil, M.D., Clinical Investigator, was inspected in Omaha, NE, and cited for multiple deficiencies related to clinical trial conduct. The inspection revealed significant issues with informed consent procedures, including failure to obtain consent, providing consent in the wrong language, and improper documentation. Additionally, the investigator failed to provide adequate oversight of study staff and maintain accurate case histories.

## Related Documents

- [EIR - 2022-01-14](https://www.globalkeysolutions.net/records/eir/andre-kalil-md/4601a00c-f951-4c1c-8b4e-f12c7ff5a30c)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/courtney-r-bratina/3ad4bfd5-d0da-4801-8e90-a5a3ba9291c3)

Company: https://www.globalkeysolutions.net/companies/andre-kalil-md/102c177d-3d38-47df-8ec3-82cbb1fc3b51

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8