# FDA 483 - Reproductive Technologies, Inc. - August 16, 2019

Source: https://www.globalkeysolutions.net/records/483/reproductive-technologies-inc/bee58ae9-e9bd-4050-81d0-da45f602ce72

> FDA 483 for Reproductive Technologies, Inc. on August 16, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Reproductive Technologies, Inc.
- Inspection Date: 2019-08-16
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Reproductive Technologies, Inc. in Berkeley, CA, revealed significant deficiencies in their human reproductive tissue operations. The firm failed to properly determine donor eligibility, adequately screen for communicable disease risks like HIV, Hepatitis B, Zika, and West Nile Virus, and maintain complete records for distributed semen. These issues indicate a serious lack of control over the safety and quality of their distributed HCT/Ps.

## Related Documents

- [WARNING_LETTER - 2019-08-16](https://www.globalkeysolutions.net/records/warning_letter/reproductive-technologies-inc/a6488682-db96-45d7-8a7f-441586fe4d89)
- [483 - 2024-11-18](https://www.globalkeysolutions.net/records/483/reproductive-technologies-inc/17dd402d-e532-4072-8270-7fee3c51c869)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/yvonne-c-wilkes/44e7b094-d09a-48f0-a0ee-f1a6506f935a)

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

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