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

Source: https://www.keypedia.com/records/eir/abington-memorial-hospital-irc/3f47449f-a71f-4b3a-a32c-7b9db2a255ea

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

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## Details

- Record Type: EIR
- 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) in Abington, PA, from June 12 to June 18, 2015, identified significant deficiencies in its operations and adherence to federal regulations governing human subject protection. The inspection, carried out under CPG 7348.809 for IRBs, resulted in the issuance of a seven-item Form FDA 483 to the IRB Chairman, Dr. G. Christensen III. Key violations included the IRB's failure to maintain a required quorum for research approvals and to follow its own written procedures for initial and continuing review of studies. Specifically, the IRB lacked written procedures for determining Significant Risk (SR) and Non-Significant Risk (NSR) for device studies, and these determinations were not documented. The facility also failed to properly maintain an accurate list of IRB members, including their qualifications and representative capacities, and lacked adequate records for ongoing study reviews. Additionally, meeting minutes were insufficiently detailed regarding attendance and recusals. The IRB inappropriately used expedited review for a Humanitarian Use Device (HUD) study, which requires full board review, and failed to promptly report the termination of a study to the Institutional Official and the FDA. Management, including Dr. Christensen and Ms. Aisha Parker, acknowledged all observations and committed to implementing corrective actions, promising a written response within 15 business days.

## Related Documents

- [483 - 2015-06-18](https://www.keypedia.com/records/483/abington-memorial-hospital-irc/2b1ec2fe-6329-424e-a822-8e32d62a46c5)
- [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

- [company_representative](https://www.keypedia.com/people/g-chris-christensen-iii/2c209982-2908-443f-bb54-88df73c12614)
- [other](https://www.keypedia.com/people/charles-gottlieb/5c7482d2-bc08-4628-9bd2-ba5465d2e779)
- [other](https://www.keypedia.com/people/michael-j-gratch/61d42090-6cab-4db0-9d1d-75108ab67b40)
- [investigator](https://www.keypedia.com/people/marcelo-o-mangalindan-jr/9fe13d26-0c5e-4559-be36-812970fa67ce)
- [company_representative](https://www.keypedia.com/people/angela-russell/b6ef3831-fba2-4456-ace5-8a656e1ffddb)

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