FDA 483 - Washington Fertility Center - October 23, 2025

An FDA inspection of Washington Fertility Center in Annandale, VA, a reproductive human tissue establishment, identified five observations related to deficiencies in donor eligibility determination, HCT/P labeling, and record-keeping. The firm failed to properly document donor eligibility before HCT/P transfer, did not label HCT/Ps from ineligible donors with required warnings, and lacked adequate procedures for communicating CMV test results. These issues indicate significant non-compliance with regulations for human cells, tissues, and cellular and tissue-based products.