FDA 483 - Women's Fertility and Health Center - April 19, 2019

The FDA issued a Form 483 to Women's Fertility and Health Center following an inspection of their human reproductive tissue establishment. The inspection revealed significant deficiencies in donor screening for communicable disease risks, a lack of established procedures for donor eligibility determination, and failures in proper identification and labeling of HCT/Ps. These issues indicate a potential risk to the safety and quality of human cells, tissues, and cellular and tissue-based products.