# FDA 483 - Chelsea Fertility NYC - October 11, 2022

Source: https://www.globalkeysolutions.net/records/483/chelsea-fertility-nyc/64326732-16aa-4fc6-b45f-c76f0c6592ac

> FDA 483 for Chelsea Fertility NYC on October 11, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chelsea Fertility NYC
- Inspection Date: 2022-10-11
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Chelsea Fertility NYC, a reproductive human tissue establishment, revealed critical deficiencies in donor screening and record-keeping. The firm failed to adequately screen oocyte donors for communicable disease risks, including West Nile Virus and Creutzfeldt-Jakob disease, and improperly deemed an ineligible donor as eligible despite positive infectious disease markers. Additionally, the facility lacked established procedures for donor screening and maintained inaccurate or illegible donor eligibility records.

## Related Documents

- [483 - 2024-11-22](https://www.globalkeysolutions.net/records/483/chelsea-fertility-nyc/9ebd0195-ad03-45fa-95da-ab26a5ac0d28)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/chelsea-fertility-nyc/2f92e33c-7fe2-48dd-a78d-d6488982bc60

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