FDA 483 - Women & Infants Hospital Of Rhode Island Women & Infants' Fertility Center - January 27, 2020

Women & Infants Hospital Of Rhode Island, a human reproductive establishment, received a Form 483 citing two observations related to donor screening. The facility failed to adequately screen an oocyte donor for Zika virus risk factors due to an incomplete medical history form. Additionally, the firm lacked established written procedures for HCT/P donor screening, specifically for medical health history interviews.