483
Piedmont Reproductive Endocrinology Group, PaPiedmont Reproductive Endocrinology Group, Pa – FDA 483, Jan 21, 2026
Record Details
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.
- Inspection date
- January 21, 2026
- Product type
- biologics
- Office
- Atlanta District Office
- Person
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ID · 39d5c76d-2a01-4481-a76d-88010c12d2fb
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