# FDA 483 - Center for Human Reproduction - February 23, 2016

Source: https://www.globalkeysolutions.net/records/483/center-for-human-reproduction/73055180-ad4c-4574-8157-0a9aedb18da3

> FDA 483 for Center for Human Reproduction on February 23, 2016. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Center for Human Reproduction
- Inspection Date: 2016-02-23
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of the Center for Human Reproduction in Manhasset, NY, identified significant issues with their anonymous oocyte donor program. The firm failed to establish and follow adequate procedures for screening and determining donor eligibility, including proper documentation and updating of donor information. These deficiencies raise concerns about the thoroughness of donor screening for communicable diseases and the accuracy of critical donor eligibility records.

## Related Documents

- [483 - 2020-03-12](https://www.globalkeysolutions.net/records/483/center-for-human-reproduction/e07b5631-22d4-4a1c-875c-c63b1e2e0a64)
- [483 - 2022-07-20](https://www.globalkeysolutions.net/records/483/center-for-human-reproduction/43086d89-7db0-4f14-88b8-9f13d10c6ef7)

## 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/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961