# FDA 483 - St. Peter's University Hospital - CPHSR - February 08, 2019

Source: https://www.globalkeysolutions.net/records/483/st-peters-university-hospital-cphsr/ab6ee55a-9c97-4a06-bf57-6bc88f703f94

> FDA 483 for St. Peter's University Hospital - CPHSR on February 08, 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: 2019-02-08
- Product Type: other
- Office Name: New Jersey District Office
- Summary: St. Peter's University Hospital - CFHSR, an Institutional Review Board in New Brunswick, NJ, was inspected by the FDA. The inspection revealed significant deficiencies in the IRB's written procedures for initial and continuing review of research, particularly for medical device studies and Humanitarian Use Devices. Additionally, the IRB failed to maintain meeting minutes with sufficient detail regarding voting records for actions taken.

## Related Documents

- [483 - 2019-07-04](https://www.globalkeysolutions.net/records/483/st-peters-university-hospital-cphsr/6ace1ff3-d2b3-486f-a871-540796f60d06)

## 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