# FDA 483 - Darrell White, M.D. - October 19, 2015

Source: https://www.globalkeysolutions.net/records/483/darrell-white-md/8bb0ccbd-44e5-44b2-97af-bb14c87a9ef5

> FDA 483 for Darrell White, M.D. on October 19, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Darrell White, M.D.
- Inspection Date: 2015-10-19
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Darrell White, M.D., a clinical investigator in Halifax Nova Scotia, revealed a significant deviation from the investigational plan. Specifically, vital signs were not consistently taken during elotuzumab infusion treatments for subjects, and a required premedication was not administered as specified in the protocol. These issues indicate a failure to ensure the investigation was conducted according to the established plan.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/stephanie-c-mangigian/0cf25e6b-1e5d-4088-a13c-11483e2380ba)

Company: https://www.globalkeysolutions.net/companies/darrell-white-md/61815ea9-e062-4293-abd0-063b3f7fc089

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