# FDA 483 - The New York Fertility Center - September 23, 2022

Source: https://www.globalkeysolutions.net/records/483/the-new-york-fertility-center/2a00a347-89f4-479a-831e-350868ad4777

> FDA 483 for The New York Fertility Center on September 23, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: The New York Fertility Center
- Inspection Date: 2022-09-23
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: The New York Fertility Center in Flushing, NY, was cited for multiple deficiencies related to its handling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to properly label HCT/Ps from donors with incomplete eligibility determinations and did not clearly identify quarantined HCT/Ps. Additionally, the center lacked adequate written procedures for the storage and limited use of products from ineligible donors.

## Related Documents

- [483 - 2019-02-27](https://www.globalkeysolutions.net/records/483/the-new-york-fertility-center/e73da565-d29c-4d78-b38b-ee48dd5ed358)
- [483 - 2021-06-15](https://www.globalkeysolutions.net/records/483/the-new-york-fertility-center/b81459f2-8f35-451a-930c-96e93755dfb6)

## Related Officers

- [Amy W. Yan-Mai](https://www.globalkeysolutions.net/people/amy-w-yan-mai/00551315-3a03-4327-ab3a-71de5c1577d4)

Company: https://www.globalkeysolutions.net/companies/the-new-york-fertility-center/07fb129e-efdd-4712-bf8a-1c95e1807ff7

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