483
Alabama Fertility Specialists, PCAlabama Fertility Specialists, PC – FDA 483, Mar 15, 2023
Record Details
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.
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