# FDA 483 - Regional Women's Health Group, LLC - July 12, 2019

Source: https://www.globalkeysolutions.net/records/483/regional-womens-health-group-llc/5ef5402e-2729-445b-b843-d82ed5afd481

> FDA 483 for Regional Women's Health Group, LLC on July 12, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Regional Women's Health Group, LLC
- Inspection Date: 2019-07-12
- Product Type: biologics
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Regional Women's Health Group, LLC, a human tissue reproductive establishment in Marlton, NJ, revealed two significant observations. The firm failed to adequately test oocyte donors for relevant communicable disease agents, specifically West Nile Virus. Additionally, donors were not properly screened for risk factors of communicable diseases, including the Zika Virus.

## Related Officers

- [Nikisha Rolden](https://www.globalkeysolutions.net/people/nikisha-rolden/ccd5f87b-fb28-493d-b0a5-2ebde50461be)

Company: https://www.globalkeysolutions.net/companies/regional-womens-health-group-llc/05ce1c44-8dea-4d43-a4f4-39c261f2145a

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8