# FDA 483 - Moore Clinical Research Inc. - March 05, 2015

Source: https://www.globalkeysolutions.net/records/483/moore-clinical-research-inc/4c537e9f-1742-47e5-8e96-c4c2e2f0f5ff

> FDA 483 for Moore Clinical Research Inc. on March 05, 2015. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Moore Clinical Research Inc.
- Inspection Date: 2015-03-05
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: During an inspection of Moore Clinical Research Inc. in Brandon, FL, the FDA observed a significant protocol deviation at this biopharmaceuticals clinical facility. An investigation was not conducted in accordance with the investigational plan, specifically regarding subject enrollment criteria. A subject was consented and randomized into a study despite being underage according to the protocol's inclusion criteria.

## Related Documents

- [483 - 2013-04-02](https://www.globalkeysolutions.net/records/483/moore-clinical-research-inc/4f9ace9a-d407-4ecb-9518-e0cfecd35214)

## 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