FDA 483 - Shady Grove Fertility - March 02, 2020

An FDA inspection of Shady Grove Fertility in Rockville, MD, a reproductive human tissue establishment, revealed critical deficiencies in donor screening processes. The firm failed to adequately screen donors for communicable disease risks, properly document reasons for donor ineligibility, and apply appropriate warning labels to human cells, tissues, and cellular and tissue-based products (HCT/Ps) from ineligible donors. These observations highlight significant concerns regarding donor eligibility determination and product safety.