# FDA 483 - St. Peter's University Hospital - CPHSR - July 04, 2019

Source: https://www.globalkeysolutions.net/records/483/st-peters-university-hospital-cphsr/6ace1ff3-d2b3-486f-a871-540796f60d06

> FDA 483 for St. Peter's University Hospital - CPHSR on July 04, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: St. Peter's University Hospital - CPHSR
- Inspection Date: 2019-07-04
- Product Type: other
- Office Name: New Jersey District Office
- Summary: An FDA inspection of St. Peter's University Hospital - CFHSR, an Institutional Review Board in New Brunswick, revealed significant deficiencies in its operations. The inspection found that the IRB lacked written procedures for conducting initial and continuing reviews of research, particularly for medical device studies and Humanitarian Use Devices. Additionally, the IRB failed to maintain meeting minutes with sufficient detail regarding voting actions.

## Related Documents

- [483 - 2019-02-08](https://www.globalkeysolutions.net/records/483/st-peters-university-hospital-cphsr/ab6ee55a-9c97-4a06-bf57-6bc88f703f94)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/michael-serrano/44c9d307-9d78-4480-b1d0-36096c056642)

Company: https://www.globalkeysolutions.net/companies/st-peters-university-hospital-cphsr/163d3f4f-bf30-4b8b-a8d4-05e13913176f

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248