# FDA 483 - Chelsea Fertility NYC - November 22, 2024

Source: https://www.globalkeysolutions.net/records/483/chelsea-fertility-nyc/9ebd0195-ad03-45fa-95da-ab26a5ac0d28

> FDA 483 for Chelsea Fertility NYC on November 22, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Chelsea Fertility NYC
- Inspection Date: 2024-11-22
- Product Type: biologics
- Office Name: New York District Office
- Summary: Chelsea Fertility NYC, a reproductive human tissue establishment in New York, was inspected by the FDA from November 18-22, 2024. The inspection revealed significant deficiencies in donor eligibility determinations, including untimely infectious disease testing, inadequate screening for communicable diseases, and improper handling of HCT/Ps prior to complete eligibility. Additionally, donor eligibility records were found to be inaccurate, illegible, or incomplete.

## Related Documents

- [483 - 2022-10-11](https://www.globalkeysolutions.net/records/483/chelsea-fertility-nyc/64326732-16aa-4fc6-b45f-c76f0c6592ac)

## 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/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d