Center For Advanced Reproductive Medicine & Fertility – FDA 483, Jul 19, 2019
The FDA inspected Center For Advanced Reproductive Medicine & Fertility in Edison, NJ, a human reproductive tissue establishment. The inspection revealed that the firm failed to test multiple anonymous oocyte donors for West Nile Virus, a relevant communicable disease agent, before determining their eligibility. Additionally, the firm's standard operating procedures were found to be deficient as they did not include West Nile Virus in the list of required infectious disease tests for gamete donors.
- Inspection date
- July 19, 2019
- Product type
- biologics
ID · c099ac92-964f-4be2-9cce-f640b9047b6a
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.