# FDA 483 - Main Line Fertility Center - June 30, 2022

Source: https://www.keypedia.com/records/483/main-line-fertility-center/e61c7beb-3bb1-4117-9062-bf1a7a332dcf

> FDA 483 for Main Line Fertility Center on June 30, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Main Line Fertility Center
- Inspection Date: 2022-06-30
- Product Type: biologics
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Main Line Fertility Center in Bryn Mawr, PA, identified two significant observations related to the handling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to quarantine HCT/Ps until donor eligibility was complete and did not properly label HCT/Ps for which donor eligibility determination was not required. These issues indicate deficiencies in the facility's procedures for ensuring the safety and compliance of reproductive tissues.

## Related Documents

- [483 - 2019-06-11](https://www.keypedia.com/records/483/main-line-fertility-center/02098c6c-adab-4b67-9ff0-6e2996aeb060)

## Related Officers

- [Kish Bolden](https://www.keypedia.com/people/kish-bolden/e24957d4-927f-40c7-a7ca-860fedce2e3f)

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

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