# FDA 483 - National Embryo Donation Center - January 12, 2023

Source: https://www.keypedia.com/records/483/national-embryo-donation-center/ea59c5f3-55d1-4b3d-b5da-b1f50796299d

> FDA 483 for National Embryo Donation Center on January 12, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: National Embryo Donation Center
- Inspection Date: 2023-01-12
- Product Type: other
- Office Name: New Orleans District Office
- Summary: The FDA inspected National Embryo Donation Center in Knoxville, TN, from January 10-12, 2023, regarding its reproductive establishment. A significant issue was identified where human cells, tissues, and cellular and tissue-based products (HCT/Ps) from sexually-intimate partners lacked required warning statements on records. This deficiency occurred when communicable disease testing was performed after cryopreservation, indicating a failure to properly inform recipients about the timing of critical donor screening.

## Related Officers

- [Christopher J. Adams](https://www.keypedia.com/people/christopher-j-adams/f7010846-7fd1-4ee8-901a-1015656fea0a)

Company: https://www.keypedia.com/companies/national-embryo-donation-center/a35d82bc-a689-4936-9038-506f8e023b36

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea