# FDA 483 - North Hudson IVF Center for Fertility & Gynecology P.C. - July 02, 2024

Source: https://www.globalkeysolutions.net/records/483/north-hudson-ivf-center-for-fertility-gynecology-pc/16656381-d54a-4c49-9e58-b2b0e6a4d9c9

> FDA 483 for North Hudson IVF Center for Fertility & Gynecology P.C. on July 02, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: North Hudson IVF Center for Fertility & Gynecology P.C.
- Inspection Date: 2024-07-02
- Product Type: biologics
- Office Name: New Jersey District Office
- Summary: North Hudson IVF Center for Fertility & Gynecology, P.C. in Englewood Cliffs, NJ, a human reproductive tissue establishment, was cited for significant deficiencies in its donor screening and record-keeping practices. The inspection revealed inadequate screening for communicable disease risk factors in oocyte donors and incomplete summaries of communicable disease test results for HCT/Ps. Furthermore, the firm lacked established and maintained procedures for donor testing, screening, and eligibility determination.

## Related Documents

- [483 - 2022-03-03](https://www.globalkeysolutions.net/records/483/north-hudson-ivf-center-for-fertility-gynecology-pc/51de1038-4118-436c-b1eb-dbdc8f0fc3cb)

## Related Officers

- [Amy Kim](https://www.globalkeysolutions.net/people/amy-kim/eee8b97a-b9d0-4709-96dc-70dbadd3a6a4)

Company: https://www.globalkeysolutions.net/companies/north-hudson-ivf-center-for-fertility-gynecology-pc/e179975f-89c6-42cd-9e56-e74b85a14682

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