# FDA 483 - VCU Health System Reproductive Medicine and IVF - November 14, 2024

Source: https://www.globalkeysolutions.net/records/483/vcu-health-system-reproductive-medicine-and-ivf/a39df32a-7c38-419b-a23d-2b497c62f04d

> FDA 483 for VCU Health System Reproductive Medicine and IVF on November 14, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: VCU Health System Reproductive Medicine and IVF
- Inspection Date: 2024-11-14
- Product Type: biologics
- Office Name: Baltimore District Office
- Summary: VCU Health System Reproductive Medicine and IVF, an HCT/Ps establishment, was cited for failing to properly screen donors for communicable disease risk factors. Specifically, the firm determined a directed donor to be eligible despite the donor's response to a medical history question indicating a risk factor. This lapse in screening could compromise the safety of donated HCT/Ps.

## Related Documents

- [483 - 2023-05-12](https://www.globalkeysolutions.net/records/483/vcu-health-system-reproductive-medicine-and-ivf/6bef0952-b718-4b64-8c96-28d0a400d2cb)

## Related Officers

- [Charles D. Boison](https://www.globalkeysolutions.net/people/charles-d-boison/b128f4a3-c1b1-409f-9291-27deb111d1e5)

Company: https://www.globalkeysolutions.net/companies/vcu-health-system-reproductive-medicine-and-ivf/3e7c5333-2daa-428c-9879-763de8516171

Office: https://www.globalkeysolutions.net/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa