FDA 483 - Virginia Center for Reproductive Medicine - February 25, 2019

The FDA inspected Virginia Center for Reproductive Medicine in Reston, VA, and issued a Form 483 with seven observations, many of which were repeat deficiencies. The inspection revealed significant issues with donor screening for communicable diseases, improper donor eligibility determinations, and inadequate record-keeping for human cells, tissues, and cellular and tissue-based products (HCT/Ps). These findings highlight persistent non-compliance in critical areas related to donor safety and quality control.