# FDA 483 - Columbia University Fertility Center - December 20, 2024

Source: https://www.globalkeysolutions.net/records/483/columbia-university-fertility-center/d3605578-ea0d-4ca5-ad36-5e88bffc2781

> FDA 483 for Columbia University Fertility Center on December 20, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Columbia University Fertility Center
- Inspection Date: 2024-12-20
- Product Type: biologics
- Office Name: New York District Office
- Summary: The FDA inspected Columbia University Fertility Center, a human reproductive tissue establishment in New York, NY, and issued a Form 483 with five observations. Deficiencies included untimely communicable disease testing for donors, improper donor eligibility determinations, and failure to label HCT/Ps from ineligible donors with biohazard warnings. The firm also lacked a standard operating procedure for releasing HCT/Ps from CMV-reactive donors.

## Related Documents

- [483 - 2019-07-23](https://www.globalkeysolutions.net/records/483/columbia-university-fertility-center/4e591f2b-44be-4395-99c1-0b5573c0df0b)
- [483 - 2022-11-28](https://www.globalkeysolutions.net/records/483/columbia-university-fertility-center/a66c8dc5-3fff-414c-94cd-864dfb7e4fc9)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/columbia-university-fertility-center/8defbab7-4935-4788-9494-a7efdbcb3339

Office: https://www.globalkeysolutions.net/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d