FDA 483 - Virginia Center for Reproductive Medicine - October 29, 2021

The FDA inspected Virginia Center for Reproductive Medicine in Reston, VA, and found significant issues with donor screening and product labeling. The firm failed to adequately screen HCT/P donors for communicable disease risk factors, including Zika virus, and used deficient medical history interview forms. Additionally, HCT/Ps from ineligible donors with reactive tests for syphilis and Hepatitis B were not properly labeled with required warning statements.