FDA 483 - Sound Fertility Care PLLC - February 06, 2020

Sound Fertility Care PLLC in Seattle, WA, was inspected regarding its human reproductive tissue operations, revealing two significant observations. The firm's donor eligibility records for sperm and oocyte donors were found to be inaccurate, with errors in determination dates and missing risk assessments. Additionally, the facility failed to adhere to its standard operating procedure for releasing HCT/Ps from donors reactive for cytomegalovirus.