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

Source: https://www.keypedia.com/records/483/reproductive-technologies-inc/43b5bdd6-ff98-4395-a929-7c35aa910636

> FDA 483 for Reproductive Technologies, Inc. on November 18, 2024. Product: biologics. 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: biologics
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Reproductive Technologies, Inc. in Berkeley, CA, was inspected from November 14-18, 2024. The inspection revealed that HCT/P donors were not determined to be eligible based on the results of donor screening and testing. Specifically, a directed donor was deemed eligible and their semen distributed despite a positive response to a screening question about UK travel between 1980-1996.

## Related Documents

- [483 - 2019-08-16](https://www.keypedia.com/records/483/reproductive-technologies-inc/bee58ae9-e9bd-4050-81d0-da45f602ce72)
- [WARNING_LETTER - 2019-08-16](https://www.keypedia.com/records/warning_letter/reproductive-technologies-inc/a6488682-db96-45d7-8a7f-441586fe4d89)
- [483 - 2024-11-18](https://www.keypedia.com/records/483/reproductive-technologies-inc/17dd402d-e532-4072-8270-7fee3c51c869)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b