# FDA 483 - Rockefeller Fertility Center - November 05, 2021

Source: https://www.keypedia.com/records/483/rockefeller-fertility-center/19530967-a004-456f-8f19-ce5f5bd91f0d

> FDA 483 for Rockefeller Fertility Center on November 05, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rockefeller Fertility Center
- Inspection Date: 2021-11-05
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Rockefeller Fertility Center in New York, NY, was inspected regarding its human reproductive tissue operations, specifically oocyte donors. The inspection revealed significant deficiencies in screening donors for communicable disease risks, particularly Zika Virus, and a failure to establish and maintain adequate donor eligibility procedures. These issues indicate a lack of proper controls for ensuring donor safety and product quality.

## Related Officers

- [Amy W Yan Mai, Investigator](https://www.keypedia.com/people/amy-w-yan-mai-investigator/061d1419-4b18-4460-9490-5a4879689834)
- [Amy Kim, Investigator](https://www.keypedia.com/people/amy-kim-investigator/1ab96d22-c129-4359-ac5f-820bc95e7842)

Company: https://www.keypedia.com/companies/rockefeller-fertility-center/f24a3b39-7552-41eb-b92f-50cf8970c5a0

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961