# FDA 483 - Center for Human Reproduction - July 20, 2022

Source: https://www.globalkeysolutions.net/records/483/center-for-human-reproduction/43086d89-7db0-4f14-88b8-9f13d10c6ef7

> FDA 483 for Center for Human Reproduction on July 20, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Center for Human Reproduction
- Inspection Date: 2022-07-20
- Product Type: other
- Office Name: Philadelphia District Office
- Summary: Northwell Health Fertility in Manhasset, NY, was inspected regarding its reproductive human tissue operations. The inspection revealed significant deficiencies in the screening and eligibility determination processes for HCT/P oocyte donors, including inadequate Zika Virus screening and untimely medical record reviews. Furthermore, the firm lacked established procedures for determining donor eligibility.

## Related Documents

- [483 - 2016-02-23](https://www.globalkeysolutions.net/records/483/center-for-human-reproduction/73055180-ad4c-4574-8157-0a9aedb18da3)
- [483 - 2020-03-12](https://www.globalkeysolutions.net/records/483/center-for-human-reproduction/e07b5631-22d4-4a1c-875c-c63b1e2e0a64)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/irina-gaberman/c863b2de-4c64-40d2-a390-289d293e5a8f)

Company: https://www.globalkeysolutions.net/companies/center-for-human-reproduction/05b72326-d78b-4faf-a666-3de9f8cfc46e

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8