# FDA 483 - GLOBAL FERTILITY & GENETICS - October 19, 2022

Source: https://www.keypedia.com/records/483/global-fertility-genetics/07c9a2d7-a71a-4585-a48a-6f73e729b5e1

> FDA 483 for GLOBAL FERTILITY & GENETICS on October 19, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GLOBAL FERTILITY & GENETICS
- Inspection Date: 2022-10-19
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of GLOBAL FERTILITY & GENETICS in New York, NY, a reproductive human tissue establishment, revealed significant deficiencies in their donor eligibility determination and screening processes. The firm failed to ensure donors were eligible based on complete screening and testing, lacked detailed screening procedures for various infectious diseases, and maintained inaccurate and illegible donor records. Additionally, donor records improperly included identifying information for anonymous donors.

## Related Documents

- [483 - 2024-12-09](https://www.keypedia.com/records/483/global-fertility-genetics/6a2caa88-f399-44f0-af6e-445756452451)

## Related Officers

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

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

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