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

Source: https://www.globalkeysolutions.net/records/483/abington-memorial-hospital-irc/5c6bdfb7-9d59-49a6-bb4f-131252f58739

> FDA 483 for Abington Memorial Hospital, IRC on June 18, 2015. Product: other. 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: other
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Abington Memorial Hospital's Institutional Review Board (IRB) in Abington, PA, revealed significant deficiencies in its operations. The inspection identified failures in maintaining proper meeting quorums, establishing written procedures for initial research review, and accurately maintaining IRB member rosters and meeting minutes. Additionally, the IRB was cited for improper expedited review procedures and inadequate reporting of study suspensions or terminations.

## Related Documents

- [483 - 2019-02-15](https://www.globalkeysolutions.net/records/483/abington-memorial-hospital-irc/496782a8-f1ef-4099-84b0-2fdf8681f66a)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/abington-memorial-hospital-irc/64ea7b53-0aee-45b0-863e-e89787625aff

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