# FDA 483 - University Reproductive Associates, P.C. - May 10, 2022

Source: https://www.keypedia.com/records/483/university-reproductive-associates-pc/3ad3c90e-b7c6-49fc-b74b-bc3bb708f97f

> FDA 483 for University Reproductive Associates, P.C. on May 10, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: University Reproductive Associates, P.C.
- Inspection Date: 2022-05-10
- Product Type: biologics
- Office Name: New Jersey District Office
- Summary: University Reproductive Associates, P.C. in Hasbrouck Heights, NJ, was cited for multiple deficiencies related to donor screening, testing, and labeling of human cells, tissues, and cellular and tissue-based products (HCT/Ps). Observations included failures to test for all relevant communicable disease agents, properly screen for risk factors, label HCT/Ps from ineligible donors, collect specimens at appropriate times, and determine donor eligibility based on complete test results. These issues indicate significant concerns regarding the safety and quality control of donor tissues.

## Related Documents

- [483 - 2023-01-19](https://www.keypedia.com/records/483/university-reproductive-associates-pc/44591c86-2752-482e-85fc-815f1a7a3dc4)

## 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