# FDA 483 - Shady Grove Fertility - October 11, 2019

Source: https://www.globalkeysolutions.net/records/483/shady-grove-fertility/d7e96975-f1ec-440f-9539-ff51b2eb1e91

> FDA 483 for Shady Grove Fertility on October 11, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shady Grove Fertility
- Inspection Date: 2019-10-11
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Shady Grove Fertility, a human tissue reproductive establishment in Arlington, VA, received a Form 483 with one observation. The inspection revealed a failure to establish and maintain adequate procedures for screening HCT/P donors. Specifically, the firm's policies and questionnaires lacked clear instructions for screening donors for Zika virus risk factors and clinical evidence of infection.

## 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/a569e412-a821-45c8-801f-e9a3d64dd9a4

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