# FDA 483 - Generation Next Fertility - May 25, 2022

Source: https://www.globalkeysolutions.net/records/483/generation-next-fertility/a3b172aa-5999-4490-8e09-12f3c3971b09

> FDA 483 for Generation Next Fertility on May 25, 2022. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Generation Next Fertility
- Inspection Date: 2022-05-25
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Generation Next Fertility in New York, NY, received a Form 483 for deficiencies in their human cells, tissues, and cellular and tissue-based products (HCT/P) donor screening and testing processes. The firm failed to properly determine donor eligibility based on screening results and lacked adequate procedures for donor testing and screening. These issues indicate a moderate severity regarding donor safety and compliance with HCT/P regulations.

## Related Documents

- [483 - 2024-01-12](https://www.globalkeysolutions.net/records/483/generation-next-fertility/8921c704-62f6-4a8c-924d-3840f6d7f725)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/generation-next-fertility/541bb461-41e8-4d7b-be1d-e73204a802a8

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