# FDA 483 - Montgomery Fertility Center - January 21, 2020

Source: https://www.globalkeysolutions.net/records/483/montgomery-fertility-center/ed3d46bd-778b-4337-a28d-11b9aed72b62

> FDA 483 for Montgomery Fertility Center on January 21, 2020. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Montgomery Fertility Center
- Inspection Date: 2020-01-21
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Montgomery Women's Medical Center PC dba Montgomery Fertility Center in Rockville, MD, a reproductive human tissue establishment, revealed significant deficiencies in donor eligibility determination processes. The firm failed to adequately screen and test anonymous oocyte donors for communicable disease agents like West Nile Virus and Zika, and lacked proper procedures and documentation for donor eligibility. These issues indicate a serious lack of control over critical aspects of HCT/P donor management.

## Related Officers

- [La-tasha M. Gunter](https://www.globalkeysolutions.net/people/la-tasha-m-gunter/db9cd9cf-db0a-4c31-9f7c-24760750f34d)

Company: https://www.globalkeysolutions.net/companies/montgomery-fertility-center/270a4839-7abc-4c88-9c81-96c8b37d35e8

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e