# FDA 483 - New York Fertility Medical Practice, PLLC - May 12, 2022

Source: https://www.globalkeysolutions.net/records/483/new-york-fertility-medical-practice-pllc/7a965670-707a-4aec-89ee-6a86fc7deb6e

> FDA 483 for New York Fertility Medical Practice, PLLC on May 12, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: New York Fertility Medical Practice, PLLC
- Inspection Date: 2022-05-12
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of New York Fertility Medical Practice, PLLC, a human reproductive tissue establishment in New York, NY, identified a significant issue regarding donor eligibility. The firm failed to determine donors ineligible even after their specimens tested reactive for communicable disease agents. Specifically, an oocyte donor who tested reactive for syphilis was still deemed eligible, and her oocytes were retrieved, fertilized, transferred, and stored.

## Related Officers

- [Amy Kim](https://www.globalkeysolutions.net/people/amy-kim/eee8b97a-b9d0-4709-96dc-70dbadd3a6a4)

Company: https://www.globalkeysolutions.net/companies/new-york-fertility-medical-practice-pllc/c2d0dd8e-f2ce-4ef7-8f4d-be134b0e4a8c

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