# FDA 483 - Mandeep Garewal - June 26, 2017

Source: https://www.globalkeysolutions.net/records/483/mandeep-garewal/6d545a89-f82c-4c64-a341-a9512ba4164c

> FDA 483 for Mandeep Garewal on June 26, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mandeep Garewal
- Inspection Date: 2017-06-26
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Mandeep Garewal, M.D., Clinical Investigator in Ormond Beach, FL, revealed a significant deviation from investigational plans. Clinical Dementia Rating testing for two protocols was not performed by trained raters as required, with an untrained employee performing the tests while the sub-investigator physician signed the forms. This indicates a serious issue with adherence to study protocols and data integrity.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/john-b-crowe/b07cb9ae-a26d-463d-abcc-0db23178d2d7)

Company: https://www.globalkeysolutions.net/companies/mandeep-garewal/4a1c160b-f3bd-40f2-8e03-9d93a7469892

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