FDA 483 - Virginia Center for Reproductive Medicine - September 20, 2023

The FDA inspected Virginia Center for Reproductive Medicine, a reproductive human tissue establishment in Reston, VA, and identified significant deficiencies in their procedures for testing HCT/P donors. The firm failed to establish and maintain adequate donor testing protocols, including issues with testing timelines, required communicable disease agent tests (HIV, HCV, HBV, WNV, Zika), and the use of an obsolete donor medical history questionnaire. These findings indicate a lack of proper controls for ensuring donor eligibility and safety.