FDA 483 - The A.R.T. Institute of Washington, Inc. - June 08, 2022

An FDA inspection of The A.R.T. Institute of Washington, Inc. in Bethesda, MD, a reproductive human tissue establishment, revealed significant deficiencies in donor eligibility determination. The firm failed to adequately test and screen donors for communicable disease agents, use FDA-licensed tests, collect samples at appropriate times, and maintain complete medical records. Additionally, the facility did not quarantine HCT/Ps properly or establish and maintain adequate written procedures for donor testing and screening.