FDA 483 - Cabell Huntington Hospital dba Center for Reproductive Medicine - August 18, 2022

An FDA inspection of Cabell Huntington Hospital dba Center for Reproductive Medicine in Huntington, WV, revealed significant deficiencies in its reproductive Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) program. The firm failed to use FDA-licensed tests for communicable disease agents in oocyte donors, did not test for relevant agents like West Nile Virus, and lacked proper screening for Zika Virus risk factors. Additionally, the facility did not establish and maintain adequate procedures for donor testing and screening.