# FDA 483 - The George Washington University Medical Faculty Associates Fertility and IVF Center - November 04, 2021

Source: https://www.globalkeysolutions.net/records/483/the-george-washington-university-medical-faculty-associates-fertility-and-ivf-center/728aa00b-b8aa-4dce-870a-437a2657d256

> FDA 483 for The George Washington University Medical Faculty Associates Fertility and IVF Center on November 04, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: The George Washington University Medical Faculty Associates Fertility and IVF Center
- Inspection Date: 2021-11-04
- Product Type: biologics
- Office Name: Office of Regulatory Affairs
- Summary: The George Washington University Medical Faculty Associates Fertility and IVF Center in Washington, DC, a reproductive human tissue establishment, was cited for multiple deficiencies during an FDA inspection. Observations primarily concerned inadequate donor screening procedures, improper donor eligibility determinations, and failures in record-keeping and labeling for Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps). These issues indicate a lack of robust controls to ensure donor safety and proper handling of HCT/Ps.

## Related Officers

- [La-tasha M. Gunter](https://www.globalkeysolutions.net/people/la-tasha-m-gunter/db9cd9cf-db0a-4c31-9f7c-24760750f34d)

Company: https://www.globalkeysolutions.net/companies/the-george-washington-university-medical-faculty-associates-fertility-and-ivf-center/690d2fba-17ac-446c-a1b7-28c475cc37c8

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