# FDA 483 - CNY Fertility, PLLC - March 17, 2022

Source: https://www.globalkeysolutions.net/records/483/cny-fertility-pllc/280ba3c3-faad-4226-b55a-99c8fb5453ae

> FDA 483 for CNY Fertility, PLLC on March 17, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CNY Fertility, PLLC
- Inspection Date: 2022-03-17
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of CNY Fertility Center in Latham, NY, a human reproductive tissue establishment, revealed that human cells, tissues, and cellular and tissue-based products (HCT/Ps) were not kept in quarantine until donor-eligibility determinations were completed. Specifically, multiple oocyte and semen donors were not fully tested for infectious diseases, including West Nile Virus, before their HCT/Ps were used or banked. This indicates a failure in critical donor screening and product safety protocols.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/marlene-l-davis/3443354d-c5b2-4515-9fa6-9037d65a895f)

Company: https://www.globalkeysolutions.net/companies/cny-fertility-pllc/f7f68b9b-c489-4ddb-a2e2-8e77ad1482dc

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