# FDA EIR - Abington Memorial Hospital, IRC - February 15, 2019

Source: https://www.keypedia.com/records/eir/abington-memorial-hospital-irc/beee86a9-4d46-4af4-b1a1-d6265659ea7c

> FDA EIR for Abington Memorial Hospital, IRC on February 15, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Abington Memorial Hospital, IRC
- Inspection Date: 2019-02-15
- Product Type: biologics
- Office Name: Philadelphia District Office
- Summary: An FDA surveillance inspection of the Abington Memorial Hospital Institutional Review Board (IRB) was conducted from February 11-15, 2019, under the Bioresearch Monitoring program (Compliance Program 7348.809). This inspection, the fourth for the facility, identified several persistent regulatory violations, some of which were repeat findings from a previous 2015 inspection. The main issues cited in the FDA Form 483 included inadequacies in IRB meeting minutes, such as inaccurate attendance records and failure to document discussions and resolutions of controverted issues (21 CFR 56.115(a)(2)). The IRB also failed to consistently advise members of research proposals approved via expedited review, as meeting minutes were not properly reviewed or approved (21 CFR 56.110(c)). Furthermore, the IRB did not always ensure a majority of members, including a nonscientific member, were present for full board research reviews (21 CFR 56.108(c)). Additional concerns raised involved allowing both primary and alternate IRB members to vote and count toward quorum, incorrect classification and communication of device risk levels, inappropriate use of expedited review for Humanitarian Use Devices, and widespread non-compliance with the IRB's own member training Standard Operating Procedures. IRB Chairman, Dr. G. Chris Christensen III, acknowledged the findings, committing to immediate corrections, including updating procedures for risk classification and training. A written response to the FDA 483 observations was promised 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 - 2015-06-18](https://www.keypedia.com/records/eir/abington-memorial-hospital-irc/3f47449f-a71f-4b3a-a32c-7b9db2a255ea)
- [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)
- [investigator](https://www.keypedia.com/people/kelly-n-kerr/6f9e1ba0-61ca-403d-a337-9efece792c21)
- [company_representative](https://www.keypedia.com/people/aisha-n-parker/d7b0f001-3510-4272-8e96-864ac0ff529b)

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