# FDA 483 - Alabama Fertility Specialists, PC - March 15, 2023

Source: https://www.keypedia.com/records/483/alabama-fertility-specialists-pc/0e9b1d3a-9757-41d8-ac96-a4f3ed1aab21

> FDA 483 for Alabama Fertility Specialists, PC on March 15, 2023. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Alabama Fertility Specialists, PC
- Inspection Date: 2023-03-15
- Product Type: other
- Office Name: New Orleans District Office
- Summary: Alabama Fertility Specialists, PC in Homewood, AL, was inspected and cited for three observations related to its handling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm lacked adequate procedures for donor screening, specifically for Zika virus risk and for releasing HCT/Ps from CMV-reactive donors. Additionally, the summary of records for HCT/Ps did not include a statement about the communicable disease testing laboratory's CLIA certification.

## Related Officers

- [Johnathan M Crayton](https://www.keypedia.com/people/johnathan-m-crayton/84dace1c-dfbe-4dcc-a9f2-f12bdd3e0c3a)

Company: https://www.keypedia.com/companies/alabama-fertility-specialists-pc/41fe0732-327b-4e50-a71e-cc9c2ae37c26

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