# FDA 483 - Abington Memorial Hospital, IRC - June 18, 2015

Source: https://www.keypedia.com/records/483/abington-memorial-hospital-irc/2b1ec2fe-6329-424e-a822-8e32d62a46c5

> FDA 483 for Abington Memorial Hospital, IRC on June 18, 2015. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Abington Memorial Hospital, IRC
- Inspection Date: 2015-06-18
- Product Type: devices
- Office Name: Philadelphia District Office
- Summary: An FDA inspection conducted at Abington Memorial Hospital's Institutional Review Board (IRB) from June 12-18, 2015, revealed several significant deficiencies in its operations. The inspection found that the IRB failed to consistently convene meetings with the required quorum for full board reviews. Key issues included a lack of written procedures for the initial review of research, particularly for determining risk levels (Significant Risk/Non-Significant Risk) for device studies. Furthermore, the IRB did not maintain complete and accurate membership rosters, with missing years and insufficient detail on members' representative capacities and relevant experience. Records of continuing review activities for ongoing studies were also found to be inadequate, and meeting minutes often contained discrepancies regarding member attendance and voting status. The inspection also noted the inappropriate use of expedited review for research that required full board consideration, specifically for the initial approval of a Humanitarian Use Device. Finally, the IRB failed to promptly report the suspension or termination of study approvals to institutional officials and the FDA. To address these observations, Abington Memorial Hospital is expected to implement comprehensive corrective actions to ensure full compliance with FDA regulations governing Institutional Review Boards and human subject protection.

## Related Documents

- [EIR - 2015-06-18](https://www.keypedia.com/records/eir/abington-memorial-hospital-irc/3f47449f-a71f-4b3a-a32c-7b9db2a255ea)
- [EIR - 2019-02-15](https://www.keypedia.com/records/eir/abington-memorial-hospital-irc/beee86a9-4d46-4af4-b1a1-d6265659ea7c)
- [483 - 2019-02-15](https://www.keypedia.com/records/483/abington-memorial-hospital-irc/4b799c30-1abc-4038-bc5e-d8fbed944162)

## Related Officers

- [investigator](https://www.keypedia.com/people/marcelo-o-mangalindan-jr/9fe13d26-0c5e-4559-be36-812970fa67ce)

Company: https://www.keypedia.com/companies/abington-memorial-hospital-irc/2e295065-0c29-480d-bff6-be3f8fafe272

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