# FDA 483 - GLOBAL FERTILITY & GENETICS - December 09, 2024

Source: https://www.globalkeysolutions.net/records/483/global-fertility-genetics/6a2caa88-f399-44f0-af6e-445756452451

> FDA 483 for GLOBAL FERTILITY & GENETICS on December 09, 2024. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GLOBAL FERTILITY & GENETICS
- Inspection Date: 2024-12-09
- Product Type: other
- Office Name: New York District Office
- Summary: GLOBAL FERTILITY & GENETICS in New York, NY, was cited on a Form 483 for deficiencies in its reproductive human tissue operations. The inspection revealed that HCT/P donors were not consistently determined eligible based on screening and testing results, leading to the use or distribution of tissues from ineligible donors. Furthermore, the firm failed to properly label HCT/Ps from ineligible donors with biohazard warnings and lacked adequate procedures for donor screening and eligibility determination.

## Related Documents

- [483 - 2022-10-19](https://www.globalkeysolutions.net/records/483/global-fertility-genetics/07c9a2d7-a71a-4585-a48a-6f73e729b5e1)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/global-fertility-genetics/75613b79-f970-4d6a-8d4e-46d13375b857

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