# FDA 483 - The New York Fertility Center - June 15, 2021

Source: https://www.globalkeysolutions.net/records/483/the-new-york-fertility-center/b81459f2-8f35-451a-930c-96e93755dfb6

> FDA 483 for The New York Fertility Center on June 15, 2021. 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: 2021-06-15
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: The New York Fertility Center in Flushing, NY, received a Form 483 for significant deficiencies in its reproductive human tissue operations. The inspection revealed failures in determining oocyte donor eligibility based on screening and testing, including issues with documentation and risk factor assessment. Additionally, the firm's standard operating procedures were found to be inadequate, and non-FDA-cleared tests were used for communicable disease screening.

## Related Documents

- [483 - 2019-02-27](https://www.globalkeysolutions.net/records/483/the-new-york-fertility-center/e73da565-d29c-4d78-b38b-ee48dd5ed358)
- [483 - 2022-09-23](https://www.globalkeysolutions.net/records/483/the-new-york-fertility-center/2a00a347-89f4-479a-831e-350868ad4777)

## Related Officers

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

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