FDA 483 - Conceptions Fertility Center - July 13, 2021

Conceptions Fertility Center in Provo, UT, a human tissue reproductive establishment, received two observations during an FDA inspection. The firm failed to adequately screen donors for communicable disease risk factors, specifically for West Nile Virus. Additionally, the summary of records for HCT/Ps did not include a listing and interpretation of all communicable disease test results, such as Hepatitis B Virus Nucleic Acid Test (HBV NAT).