# FDA 483 - Samer Nakhle, M.D. - June 30, 2017

Source: https://www.keypedia.com/records/483/samer-nakhle-md/bb4688f4-276d-4768-a6d5-b83271c2c29b

> FDA 483 for Samer Nakhle, M.D. on June 30, 2017. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Samer Nakhle, M.D.
- Inspection Date: 2017-06-30
- Product Type: drugs
- Office Name: San Francisco District Office
- Summary: An FDA Form 483 was issued to Samer Nakhle, M.D., operating as Palm Medical Research Center in Las Vegas, NV, following an inspection from June 26 to June 30, 2017. The inspection revealed a significant deviation from regulatory expectations concerning the conduct of a clinical investigation. The primary observation indicated that the investigation was not performed in accordance with the signed statement of the investigator and the investigational plan. Specifically, four study subjects were enrolled who did not meet the required inclusion criteria related to birth control methods. A serious consequence of this non-compliance was that one of these subjects became pregnant, which ultimately resulted in the termination of the pregnancy. This observation underscores the importance of strict adherence to protocols for patient safety and data reliability in clinical trials. The FDA 483 is an inspectional observation, not a final determination, but it necessitates a response from the firm to address the findings, implement corrective actions, or discuss objections to ensure compliance with regulatory standards for medical research.

## Related Documents

- [483 - 2017-06-30](https://www.keypedia.com/records/483/samer-nakhle-md/2187d1f2-43f7-4e76-96b9-6deb0e6b690a)

## Related Officers

- [Clinical Investigator](https://www.keypedia.com/people/samer-nakhle/664af937-346f-41b3-9bf7-a3d63feac297)
- [investigator](https://www.keypedia.com/people/humberto-z-gomez/6de682f6-ae2a-45ff-92ab-ba6ac7bb97b4)

Company: https://www.keypedia.com/companies/samer-nakhle-md/8939cfe3-6e8a-447d-a8fc-757e3cc18bf5

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df