FDA 483 - Center for Reproductive Health Fertility Laboratory of Nashville - February 23, 2024

The Center for Reproductive Health Fertility Laboratory of Nashville received a Form 483 following an inspection from February 22-23, 2024. The inspection revealed a significant issue with record-keeping for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Specifically, donor names were improperly included in the records of eight anonymous oocyte donors.