# FDA 483 - Reproductive Technologies, Inc. - November 18, 2024

Source: https://www.globalkeysolutions.net/records/483/reproductive-technologies-inc/17dd402d-e532-4072-8270-7fee3c51c869

> FDA 483 for Reproductive Technologies, Inc. on November 18, 2024. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Reproductive Technologies, Inc.
- Inspection Date: 2024-11-18
- Product Type: other
- Office Name: San Francisco District Office
- Summary: An FDA inspection of Reproductive Technologies, Inc. in Berkeley, CA, from November 14-18, 2024, revealed a significant deficiency in donor eligibility determination. The firm failed to properly screen and test HCT/P donors, specifically distributing semen from a donor who reported extensive travel to the UK during a period associated with CJD risk. This indicates a serious lapse in donor screening protocols.

## Related Documents

- [483 - 2019-08-16](https://www.globalkeysolutions.net/records/483/reproductive-technologies-inc/bee58ae9-e9bd-4050-81d0-da45f602ce72)
- [WARNING_LETTER - 2019-08-16](https://www.globalkeysolutions.net/records/warning_letter/reproductive-technologies-inc/a6488682-db96-45d7-8a7f-441586fe4d89)

## Related Officers

- [Emily S. McGann](https://www.globalkeysolutions.net/people/emily-s-mcgann/43891ff3-bd70-4337-b61c-e16cc7ad0468)

Company: https://www.globalkeysolutions.net/companies/reproductive-technologies-inc/81a46c28-125d-4e9e-ba8b-1d521dff2b44

Office: https://www.globalkeysolutions.net/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df