# FDA 483 - Poma Fertility, LLC - June 19, 2019

Source: https://www.globalkeysolutions.net/records/483/poma-fertility-llc/684a43b8-96de-4458-8857-23d41d76bc24

> FDA 483 for Poma Fertility, LLC on June 19, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Poma Fertility, LLC
- Inspection Date: 2019-06-19
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Poma Fertility, LLC, a human reproductive tissue establishment in Kirkland, WA, revealed significant deficiencies in their donor eligibility determination processes. The firm failed to adequately screen and test HCT/P donors for communicable disease agents, including West Nile Virus and Zika, and did not properly evaluate risk factors like recent tattooing. Furthermore, the inspection found a lack of established, defined, and documented procedures for donor testing, screening, and eligibility determinations.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/peter-s-kessler/f3a9dea7-3a2d-4c86-9ec6-97791f9b6c21)

Company: https://www.globalkeysolutions.net/companies/poma-fertility-llc/88380adb-3dc2-49d8-9fd3-de14a992b907

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822