# FDA 483 - Give Legacy - December 01, 2021

Source: https://www.keypedia.com/records/483/give-legacy/41898845-2f64-4aa7-ae83-dcb379a6a12d

> FDA 483 for Give Legacy on December 01, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Give Legacy
- Inspection Date: 2021-12-01
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Kokopelli Technologies, dba Embryodirector.com, in San Antonio, TX, identified a significant issue regarding the labeling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Specifically, Sexually Intimate Partner (SIP) semen samples intended for autologous use were not properly labeled "For Autologous Use Only" and "Not Evaluated for Infectious Substances," and donor eligibility determinations were not performed for these samples prior to storage and shipment to cryo-preservation banks. This indicates a failure to ensure appropriate controls for HCT/Ps.

## Related Officers

- [investigator](https://www.keypedia.com/people/richard-t-riggie/d07a4551-08b4-44f7-b7d2-02ae3c5dc1e2)

Company: https://www.keypedia.com/companies/give-legacy/4dbaf2e3-e94c-45b0-a7fc-7686ed733f88

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab