# FDA 483 - Fertility Answers LLC - December 06, 2022

Source: https://www.keypedia.com/records/483/fertility-answers-llc/419c2a3b-4247-4d73-8077-7cc706927d28

> FDA 483 for Fertility Answers LLC on December 06, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fertility Answers LLC
- Inspection Date: 2022-12-06
- Product Type: other
- Office Name: New Orleans District Office
- Summary: Fertility Answers LLC in Lafayette, LA, received a Form FDA 483 for deficiencies in donor screening and eligibility determination for human cells, tissues, and cellular and tissue-based products (HCT/Ps). The inspection revealed failures to screen for Zika virus risk factors, properly document donor eligibility, and ensure communicable disease testing was performed by a CLIA-certified laboratory. These observations indicate a need for improved donor qualification processes.

## Related Officers

- [Johnathan M Crayton](https://www.keypedia.com/people/johnathan-m-crayton/84dace1c-dfbe-4dcc-a9f2-f12bdd3e0c3a)
- [FDA_PERSONNEL](https://www.keypedia.com/people/edward-a-brunt/f823f6cb-7fb1-422b-b022-cb0d673f6210)

Company: https://www.keypedia.com/companies/fertility-answers-llc/b065cbed-d30f-4737-94b1-0f68515ab8e5

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea