# FDA 483 - Memorial Hospital of Rhode Island IRB - April 17, 2019

Source: https://www.globalkeysolutions.net/records/483/memorial-hospital-of-rhode-island-irb/69f0e157-6ec4-4664-83ae-5aba68a2ef41

> FDA 483 for Memorial Hospital of Rhode Island IRB on April 17, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Memorial Hospital of Rhode Island IRB
- Inspection Date: 2019-04-17
- Product Type: other
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Memorial Hospital of Rhode Island IRB in Pawtucket, RI, identified a significant deficiency in the maintenance of Institutional Review Board (IRB) meeting minutes. The IRB failed to adequately document voting actions for FDA-regulated studies, indicating a lapse in record-keeping procedures. This observation highlights a need for improved detail in recording IRB decisions and votes.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/victoria-m-daddeo/f1832c5e-d242-4e1a-8c30-4c951c3976ea)

Company: https://www.globalkeysolutions.net/companies/memorial-hospital-of-rhode-island-irb/f7882a1d-f792-46ca-9649-e88c92003cfa

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7