FDA 483 - Brigham And Women's Hospital - September 26, 2019

Brigham And Women's Hospital in Boston received a Form 483 for deficiencies in donor screening and testing procedures. The inspection revealed that the firm failed to test oocyte and semen donors for West Nile Virus during specific seasonal periods and lacked adequate screening forms and established procedures for donor eligibility determination. These issues indicate a significant lapse in ensuring the safety of human cells, tissues, and cellular and tissue-based products (HCT/Ps).