# FDA 483 - University Reproductive Associates, P.C. - January 19, 2023

Source: https://www.keypedia.com/records/483/university-reproductive-associates-pc/44591c86-2752-482e-85fc-815f1a7a3dc4

> FDA 483 for University Reproductive Associates, P.C. on January 19, 2023. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: University Reproductive Associates, P.C.
- Inspection Date: 2023-01-19
- Product Type: other
- Office Name: New Jersey District Office
- Summary: An FDA inspection of University Reproductive Associates, P.C. in Hasbrouck Heights, NJ, a human tissue reproductive establishment, revealed significant deficiencies in donor screening practices. The firm failed to adequately screen oocyte and semen donors for communicable disease risk factors, including West Nile Virus and Zika Virus. Additionally, the facility's written procedures were not designed to ensure compliance with donor eligibility requirements, lacking specific screening protocols for several infectious agents.

## Related Documents

- [483 - 2022-05-10](https://www.keypedia.com/records/483/university-reproductive-associates-pc/3ad3c90e-b7c6-49fc-b74b-bc3bb708f97f)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/emily-a-walters/e80b3581-ffba-4244-9030-b6c9496da932)

Company: https://www.keypedia.com/companies/university-reproductive-associates-pc/3e92c563-d266-4c4a-88fa-0d7745364b68

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248