# FDA 483 - St. Agnes Medical Center IRB - September 01, 2022

Source: https://www.globalkeysolutions.net/records/483/st-agnes-medical-center-irb/764fd2b7-094b-4d60-941e-3343f2993866

> FDA 483 for St. Agnes Medical Center IRB on September 01, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: St. Agnes Medical Center IRB
- Inspection Date: 2022-09-01
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: St. Agnes Medical Center IRB in Fresno, CA, was cited for multiple deficiencies related to its operations and record-keeping during an FDA inspection. The observations highlight failures in maintaining accurate IRB member rosters, detailed meeting minutes, and proper reporting to the FDA regarding operational changes and discontinuation. Additionally, the IRB did not renew its registration, lacked policies for device risk determinations, and failed to retain required research records.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/humberto-z-gomez/6de682f6-ae2a-45ff-92ab-ba6ac7bb97b4)

Company: https://www.globalkeysolutions.net/companies/st-agnes-medical-center-irb/0cefcc5e-3e8f-4208-9110-916e5936d060

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b