# FDA 483 - Moore Clinical Research Inc. - April 02, 2013

Source: https://www.globalkeysolutions.net/records/483/moore-clinical-research-inc/4f9ace9a-d407-4ecb-9518-e0cfecd35214

> FDA 483 for Moore Clinical Research Inc. on April 02, 2013. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Moore Clinical Research Inc.
- Inspection Date: 2013-04-02
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Moore Clinical Research, Inc. in Brandon, FL, a clinical investigator, was cited for significant deficiencies during an FDA inspection. Observations included the Principal Investigator's failure to personally supervise the study and delegating screening physicals to unqualified staff. Additionally, the firm failed to promptly report a subject safety concern to the IRB and did not ensure informed consent was provided in language understandable to subjects.

## Related Documents

- [483 - 2015-03-05](https://www.globalkeysolutions.net/records/483/moore-clinical-research-inc/4c537e9f-1742-47e5-8e96-c4c2e2f0f5ff)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/gene-r-gunn/3c011052-9264-461e-a92e-4af3cc26819c)

Company: https://www.globalkeysolutions.net/companies/moore-clinical-research-inc/697a31e4-ad5b-4bc3-a70c-d9ecefa5f772

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6