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

Source: https://www.keypedia.com/records/483/global-fertility-genetics/6c889e4b-c1f2-4203-9ee4-a8e5361a2a93

> 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: Food and Drug Administration
- Summary: GLOBAL FERTILITY & GENETICS received an FDA Form 483 following an inspection conducted from October 13 to October 19, 2022. The inspection, focusing on reproductive human tissue operations, identified several significant issues concerning donor eligibility and record-keeping practices.
A primary observation noted that donor eligibility for human tissue products was not consistently determined based on complete screening and testing results. For instance, eligibility was sometimes finalized before receiving all infectious disease test reports, such as for West Nile Virus. Additionally, donor questionnaires were found to be incomplete, lacking critical information regarding potential health risks.
Furthermore, the firm's standard operating procedures for screening both anonymous and directed tissue donors were deemed inadequate. These procedures lacked detailed eligibility criteria for infectious agents like West Nile Virus, specific risks for Hepatitis infection, and genetic conditions such as Creutzfeldt-Jacob disease. The FDA also observed that records for anonymous oocyte donors improperly included donor names, violating privacy and anonymity protocols. Lastly, donor eligibility records exhibited inaccuracies, with important dates being overwritten, compromising their legibility and integrity.
These observations highlight a need for GLOBAL FERTILITY & GENETICS to review and revise its donor screening protocols and record management to ensure full compliance with federal regulations for human tissue products, thereby safeguarding public health and maintaining data accuracy. The firm is expected to address these findings.

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## 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/food-and-drug-administration/437fdb2a-5048-42aa-aaea-ea28efe65516