FDA 483 - Virginia Fertility & IVF - August 31, 2021

Virginia Fertility & IVF in Charlottesville, VA, was inspected regarding its reproductive HCT/Ps. The inspection revealed deficiencies in donor eligibility determination, specifically concerning West Nile Virus testing for egg donors during the WNV season. Additionally, the firm's standard operating procedures were found to be inadequate in addressing donor eligibility requirements related to WNV risk factors.