FDA 483 - Denker, Mark S, MD PA - June 06, 2022

An FDA inspection of Mark S. Denker, M.D., PA, a reproductive tissue establishment in Boca Raton, FL, revealed significant deficiencies in donor screening, eligibility determination, record-keeping, and labeling practices for HCT/Ps. The firm failed to adequately screen donors for communicable disease risk factors, maintain proper documentation, and correctly interpret test results. Several observations were repeats from a previous inspection, indicating persistent issues.