# FDA 483 - Shady Grove Fertility - March 02, 2020

Source: https://www.globalkeysolutions.net/records/483/shady-grove-fertility/c09cb123-7c87-401b-9e6f-daad362935f7

> FDA 483 for Shady Grove Fertility on March 02, 2020. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shady Grove Fertility
- Inspection Date: 2020-03-02
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: An FDA inspection of Shady Grove Fertility in Rockville, MD, a reproductive human tissue establishment, revealed critical deficiencies in donor screening processes. The firm failed to adequately screen donors for communicable disease risks, properly document reasons for donor ineligibility, and apply appropriate warning labels to human cells, tissues, and cellular and tissue-based products (HCT/Ps) from ineligible donors. These observations highlight significant concerns regarding donor eligibility determination and product safety.

## 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/shady-grove-fertility/8d611b52-a0dc-4684-92f9-65cef6a3d8e4

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