# FDA 483 - Fertility Answers LLC - December 08, 2022

Source: https://www.keypedia.com/records/483/fertility-answers-llc/3e74ba85-5d74-42ef-a078-f31151f812b7

> FDA 483 for Fertility Answers LLC on December 08, 2022. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Fertility Answers LLC
- Inspection Date: 2022-12-08
- Product Type: other
- Office Name: New Orleans District Office
- Summary: Fertility Answers LLC, a fertility clinic in Baton Rouge, LA, received a Form 483 for three observations related to donor screening and eligibility for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The inspection found deficiencies in screening donors for communicable disease risks, including ZIKV, documenting donor eligibility, and ensuring contract laboratories performing communicable disease testing were CLIA certified. These issues indicate a moderate level of non-compliance with HCT/P regulations.

## 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/f2610a31-83e6-419d-8950-36c430e5ad61

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