# FDA 483 - John Muir Medical Center IRB #1 - October 15, 2021

Source: https://www.keypedia.com/records/483/john-muir-medical-center-irb-1/cfd59bfe-603d-4db6-9745-ca21e79a4468

> FDA 483 for John Muir Medical Center IRB #1 on October 15, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: John Muir Medical Center IRB #1
- Inspection Date: 2021-10-15
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of John Muir Medical Center IRB #1 in Concord, CA, revealed two significant observations. The inspection found deficiencies in the preparation and maintenance of IRB meeting minutes, specifically regarding the documentation of actions taken and vote counts. Additionally, the IRB was cited for not including at least one member who is not otherwise affiliated with the institution, as required.

## Related Officers

- [investigator](https://www.keypedia.com/people/dustin-r-abaonza/0a9994bd-d6ab-47cc-8f1b-5bf4d10bd852)

Company: https://www.keypedia.com/companies/john-muir-medical-center-irb-1/279da0a5-e79d-4d51-a310-9a4b8d634296

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