# FDA 483 - Eastern Virginia Medical School IRB - May 03, 2019

Source: https://www.globalkeysolutions.net/records/483/eastern-virginia-medical-school-irb/a8dbe375-a132-4d03-b97e-edc943218a70

> FDA 483 for Eastern Virginia Medical School IRB on May 03, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eastern Virginia Medical School IRB
- Inspection Date: 2019-05-03
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Eastern Virginia Medical School IRB identified significant deficiencies in record-keeping practices. The firm failed to properly maintain updated lists of IRB members and ensure the accuracy and detail of IRB meeting minutes. These issues indicate a lack of adequate control over essential documentation for institutional review board operations.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/melanie-n-daniels/51d7ddf0-f1af-4e42-ba4c-9a18200f42a9)

Company: https://www.globalkeysolutions.net/companies/eastern-virginia-medical-school-irb/e87d4fcc-4758-4d41-abfc-1e33f55a0175

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e