# FDA 483 - Main Line Fertility Center - June 11, 2019

Source: https://www.globalkeysolutions.net/records/483/main-line-fertility-center/02098c6c-adab-4b67-9ff0-6e2996aeb060

> FDA 483 for Main Line Fertility Center on June 11, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Main Line Fertility Center
- Inspection Date: 2019-06-11
- Product Type: biologics
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Main Line Fertility Center in Bryn Mawr, PA, identified a significant deficiency in their donor screening procedures. The facility failed to adequately screen 17 out of 20 anonymous oocyte donors for all relevant Zika Virus risk factors, a designated communicable disease. This lapse indicates a failure to ensure proper screening for communicable disease agents in human tissue for reproductive use.

## Related Documents

- [483 - 2022-06-30](https://www.globalkeysolutions.net/records/483/main-line-fertility-center/e61c7beb-3bb1-4117-9062-bf1a7a332dcf)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/main-line-fertility-center/a81b1746-1c4b-496b-a068-7c8b3fea7e9c

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