# FDA 483 - Pablo J. Sanchez, M.D., Principal Investigator - October 22, 2012

Source: https://www.keypedia.com/records/483/pablo-j-sanchez-md-principal-investigator/0e8f7395-d1a6-4609-ba99-33f03ece5e6a

> FDA 483 for Pablo J. Sanchez, M.D., Principal Investigator on October 22, 2012. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Pablo J. Sanchez, M.D., Principal Investigator
- Inspection Date: 2012-10-22
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Pablo J. Sanchez, M.D., Principal Investigator, revealed significant deficiencies in the conduct of a clinical investigation. Observations included a failure to ensure IRB approval for study procedures, deviations from the investigational plan regarding specimen handling and concomitant medication recording, and inadequate maintenance of case histories and informed consent documentation. These findings indicate a lack of proper oversight and record-keeping during the study.

## Related Officers

- [Amanda J. White](https://www.keypedia.com/people/amanda-j-white/75a2f1a0-0b57-4aba-a945-094b66efe69b)
- [Investigator](https://www.keypedia.com/people/elisa-m-fleming/bfb8308a-9b37-4051-90f2-66066c26e1f4)

Company: https://www.keypedia.com/companies/pablo-j-sanchez-md-principal-investigator/b83aa1c5-e809-4a20-b981-33f3df628b03

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9