FDA 483 - Empire Medical Practice, PC d.b.a Kindbody - September 03, 2021

An FDA inspection of Empire Medical Practice, PC d.b.a Kindbody in New York, NY, a reproductive human tissue establishment, revealed one significant observation. The firm failed to ensure HCT/P donors were determined eligible based on complete donor screening and testing results. Specifically, a donor was deemed eligible before all communicable disease test results were available.