FDA 483 - Piedmont Reproductive Endocrinology Group, Pa - January 21, 2026

Piedmont Reproductive Endocrinology Group, Pa in Greenville, SC was inspected by the FDA from January 16-21, 2026. The inspection revealed a significant issue regarding donor screening procedures for anonymous oocyte donors. The firm failed to perform complete physical examinations within the required six-month timeframe, instead using abbreviated screening methods, which led to the use of oocytes from inadequately screened donors.