FDA 483 - Piedmont Reproductive Endocrinology Group, PA - January 09, 2026

Piedmont Reproductive Endocrinology Group, PA in West Columbia, SC was inspected regarding its HCT/P operations, specifically anonymous oocyte donor screening. The inspection revealed that the firm used abbreviated donor screening procedures for donors who lacked a complete screening within the previous six months. Additionally, the firm failed to establish and maintain written procedures for HCT/P donor screening, particularly for its abbreviated assessment form.