# FDA 483 - Medstar Health Research Institute IRB - January 10, 2018

Source: https://www.keypedia.com/records/483/medstar-health-research-institute-irb/73e678a0-934e-438d-b867-09f2240ab47d

> FDA 483 for Medstar Health Research Institute IRB on January 10, 2018. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medstar Health Research Institute IRB
- Inspection Date: 2018-01-10
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: MedStar Health Research Institute, an IRB in Hyattsville, MD, was cited for four observations during an FDA inspection from January 8-10, 2018. The observations primarily concern the IRB's failure to adhere to its own written procedures for review, maintain accurate member rosters, ensure proper voting and quorum at convened meetings, and retain copies of all reviewed research proposals. These issues indicate deficiencies in the IRB's oversight and record-keeping practices.

## Related Officers

- [investigator](https://www.keypedia.com/people/john-dan/8a8c42e4-66ec-438d-868e-f32461f9026c)

Company: https://www.keypedia.com/companies/medstar-health-research-institute-irb/e0ac174f-d56e-45c8-a408-c6f66be0996f

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