# FDA 483 - Mercy Catholic Medical Center Institutional Review Board - November 06, 2017

Source: https://www.keypedia.com/records/483/mercy-catholic-medical-center-institutional-review-board/3f30469a-3931-436b-bf29-7ee2d7b544bd

> FDA 483 for Mercy Catholic Medical Center Institutional Review Board on November 06, 2017. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mercy Catholic Medical Center Institutional Review Board
- Inspection Date: 2017-11-06
- Product Type: Devices
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Mercy Catholic Medical Center's Institutional Review Board was conducted from October 25 to November 6, 2017. The inspection identified a key observation related to the organization's adherence to federal regulations. Specifically, the IRB was found to lack prepared and maintained written procedures, which is a requirement under 21 CFR 56.108(a) and (b). This regulatory framework mandates that IRBs have documented operational guidelines. The central issue highlighted was the absence of written procedures for implementing cooperative IRB review arrangements, such as joint reviews or reliance on other qualified IRBs, which aim to avoid duplication of effort. This indicates a gap in the IRB's framework for overseeing human subject research, especially in collaborative scenarios. The company indicated a promise to correct this observation. To resolve this, Mercy Catholic Medical Center is required to develop and implement thorough written procedures for all cooperative review arrangements, ensuring complete compliance with the specified federal regulations.

## Related Officers

- [investigator](https://www.keypedia.com/people/stephanie-c-mangigian/0cf25e6b-1e5d-4088-a13c-11483e2380ba)
- [Institutional Review Board Chair](https://www.keypedia.com/people/james-roberts/48426808-1955-4f29-8d39-722fb60777c0)

Company: https://www.keypedia.com/companies/mercy-catholic-medical-center-institutional-review-board/c0173179-ab3d-4a04-8b22-d069decc62cc

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