483
Fertility and Advanced Reproductive Medicine at UTSWFertility and Advanced Reproductive Medicine at UTSW – FDA 483, Dec 13, 2023
Record Details
An FDA inspection of Fertility and Advanced Reproductive Medicine at UTSW in Dallas, TX, revealed significant issues with donor eligibility and HCT/P handling. The firm failed to ensure donor testing was negative for communicable disease agents, maintain proper documentation of donor eligibility, and adequately screen donors for disease risk factors. Additionally, HCT/Ps not requiring eligibility determination lacked appropriate warning labels.
- Inspection date
- December 13, 2023
- Product type
- biologics
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ID · 2150a048-de3b-4cbb-b233-a0dca5cb4dbd
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