# FDA 483 - Medical City Plano IRB - December 06, 2024

Source: https://www.keypedia.com/records/483/medical-city-plano-irb/79e9761e-1cef-477a-bd70-74d8f6f04fd9

> FDA 483 for Medical City Plano IRB on December 06, 2024. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medical City Plano IRB
- Inspection Date: 2024-12-06
- Product Type: other
- Office Name: Dallas District Office
- Summary: An FDA inspection of Medical City Plano IRB in Plano, TX, revealed two significant observations. The firm failed to prepare and maintain IRB meeting minutes with sufficient detail regarding voting actions, including issues with recusal and abstention documentation. Additionally, the IRB lacked written procedures for conducting its initial review of research, specifically concerning chairman voting, quorum, and the distinction between abstentions and recusals.

## Related Officers

- [Iris C. Macinnes](https://www.keypedia.com/people/iris-c-macinnes/5e8d7fef-18d5-453d-82b2-19e8e2897d26)
- [Korina Serrano](https://www.keypedia.com/people/korina-serrano/c96035ff-7eb6-4049-ab6f-248c3c959c3b)

Company: https://www.keypedia.com/companies/medical-city-plano-irb/ebb523c1-1de1-4776-a665-817dc52c80ec

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9