# FDA 483 - Shannon R. Schrader, M.D. - March 03, 2020

Source: https://www.keypedia.com/records/483/shannon-r-schrader-md/0cb83a09-4aeb-45a8-9be8-a7449a7fbe8c

> FDA 483 for Shannon R. Schrader, M.D. on March 03, 2020. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Shannon R. Schrader, M.D.
- Inspection Date: 2020-03-03
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: Research Access Network in Houston, TX, was cited for significant deficiencies in its clinical trial conduct. Observations included failures to follow the investigator's statement regarding subject procedures and visits, inadequate investigational drug disposition records, and a critical failure to obtain proper informed consent from human subjects. These issues indicate a lack of adherence to study protocols and regulatory requirements.

## Related Officers

- [investigator](https://www.keypedia.com/people/zerita-white/82b19f0c-bd17-4a44-8523-8986f38851a8)

Company: https://www.keypedia.com/companies/shannon-r-schrader-md/8bdbeb81-6983-4a71-8165-9660ecc7ef00

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