# FDA 483 - Women's Fertility and Health Center - April 19, 2019

Source: https://www.globalkeysolutions.net/records/483/womens-fertility-and-health-center/732d8661-51af-4294-8704-6642b08165a0

> FDA 483 for Women's Fertility and Health Center on April 19, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Women's Fertility and Health Center
- Inspection Date: 2019-04-19
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: The FDA issued a Form 483 to Women's Fertility and Health Center following an inspection of their human reproductive tissue establishment. The inspection revealed significant deficiencies in donor screening for communicable disease risks, a lack of established procedures for donor eligibility determination, and failures in proper identification and labeling of HCT/Ps. These issues indicate a potential risk to the safety and quality of human cells, tissues, and cellular and tissue-based products.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/shavon-l-square/6a15df34-1af6-44f7-8874-c8606691f7e0)

Company: https://www.globalkeysolutions.net/companies/womens-fertility-and-health-center/1a4d9668-2519-45c8-b887-8c070ecf646c

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