FDA 483 - Cabell Huntington Hospital dba Center for Reproductive Medicine - August 18, 2022
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
- Inspection Date
- August 18, 2022
- Product Type
- Biologics
ID · ec1a9f81-6324-4ebd-89a8-82d0385d6323