# FDA 483 - Ranee  Mehra, M.D., Clinical Investigator - February 11, 2014

Source: https://www.globalkeysolutions.net/records/483/ranee-mehra-md-clinical-investigator/8e970c1b-2fc0-4386-adc5-00769c8f0630

> FDA 483 for Ranee  Mehra, M.D., Clinical Investigator on February 11, 2014. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ranee  Mehra, M.D., Clinical Investigator
- Inspection Date: 2014-02-11
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Fox Chase Cancer Center in Philadelphia revealed that an investigation was not conducted in accordance with the investigation plan. Specifically, issues were noted with patient inclusion criteria documentation, incomplete CT/MRI scan assessments, and missing ECGs for multiple patients. These deficiencies indicate a failure to adhere to study protocol and proper data collection procedures.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/michael-j-nerz/6f5d7914-524b-48be-bda3-26e10b21529a)

Company: https://www.globalkeysolutions.net/companies/ranee-mehra-md-clinical-investigator/be07ee22-c3e4-4cf2-895f-f2d268412eed

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8