# FDA 483 - VCU Health System Reproductive Medicine and IVF - May 12, 2023

Source: https://www.globalkeysolutions.net/records/483/vcu-health-system-reproductive-medicine-and-ivf/6bef0952-b718-4b64-8c96-28d0a400d2cb

> FDA 483 for VCU Health System Reproductive Medicine and IVF on May 12, 2023. 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: 2023-05-12
- Product Type: biologics
- Office Name: Office of Regulatory Affairs
- Summary: VCU Health System Reproductive Medicine and IVF in Richmond, VA, received a Form FDA 483 with three observations during an inspection of its Reproductive HCT/P operations. The observations primarily concern deficiencies in donor eligibility determinations and record-keeping practices. Issues included the absence of summary records for HCT/Ps, failure to interpret infectious disease test results, and inadequate documentation of reasons for donor ineligibility.

## Related Documents

- [483 - 2024-11-14](https://www.globalkeysolutions.net/records/483/vcu-health-system-reproductive-medicine-and-ivf/a39df32a-7c38-419b-a23d-2b497c62f04d)

## Related Officers

- [Richard J. Bashay](https://www.globalkeysolutions.net/people/richard-j-bashay/ce50702d-1f5b-42c5-b50a-88bb43cba196)

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

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64