# FDA 483 - UPMC Susquehanna Williamsport Regional Medical Center - March 29, 2018

Source: https://www.keypedia.com/records/483/upmc-susquehanna-williamsport-regional-medical-center/dcbe266f-b1a2-4c03-88f6-9089034e4d3e

> FDA 483 for UPMC Susquehanna Williamsport Regional Medical Center on March 29, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: UPMC Susquehanna Williamsport Regional Medical Center
- Inspection Date: 2018-03-29
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection conducted on March 28-29, 2018, at UPMC Susquehanna's Institutional Review Board (IRB) in Williamsport, PA, identified several significant issues related to its operations. The inspection highlighted a failure to comply with regulatory expectations for IRBs, which are crucial for protecting human research subjects. Key violations included the IRB lacking at least one unaffiliated member throughout 2016, a foundational requirement for independent oversight. Additionally, the IRB consistently failed to conduct continuing reviews of research protocols within the mandated annual intervals, leading to periods where study approvals had lapsed. The company also used an expedited review procedure without adequately advising all IRB members of approved research during subsequent convened meetings.A critical observation was the absence of maintained written procedures, as the 'Susquehanna Health IRB Charter Policy' had expired in February 2018, despite the IRB continuing its review and approval activities. Finally, informed consent documents for certain protocols did not include the necessary statement informing participants of the possibility of FDA inspection of their records. To address these findings, UPMC Susquehanna must revise its IRB membership, ensure timely continuing reviews, implement proper communication for expedited approvals, update its written procedures, and amend informed consent forms to comply with regulatory requirements.

## Related Officers

- [M.D.](https://www.keypedia.com/people/william-keenan/507eb14c-6462-496c-9003-122a739171cc)
- [investigator](https://www.keypedia.com/people/kelly-n-kerr/6f9e1ba0-61ca-403d-a337-9efece792c21)

Company: https://www.keypedia.com/companies/upmc-susquehanna-williamsport-regional-medical-center/695d107d-be4d-4c3b-ad09-e253055f78bb

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