# FDA 483 - Women & Infants Hospital IRB - January 11, 2017

Source: https://www.globalkeysolutions.net/records/483/women-infants-hospital-irb/2549a252-a037-443e-b5a0-9fd0e7943c48

> FDA 483 for Women & Infants Hospital IRB on January 11, 2017. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Women & Infants Hospital IRB
- Inspection Date: 2017-01-11
- Product Type: other
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Women and Infants Institutional Review Board in Providence, RI, revealed two significant issues. The IRB failed to maintain sufficiently detailed meeting minutes and did not conduct continuing review of research at appropriate intervals based on risk. These observations indicate deficiencies in the IRB's oversight and record-keeping practices.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/victoria-m-daddeo/dbd92345-27c5-43fe-beb4-b1b5974bec05)

Company: https://www.globalkeysolutions.net/companies/women-infants-hospital-irb/168f65fc-a459-4eee-8c55-30300e012b2a

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