483
Rejuvenating Fertility Center PLLCRejuvenating Fertility Center PLLC – FDA 483, Oct 25, 2024
Record Details
An FDA inspection of Rejuvenating Fertility Center PLLC in Westport, CT, revealed significant deficiencies in their human reproductive tissue operations. The firm failed to establish adequate procedures for HCT/P donor screening and did not collect donor specimens for communicable disease testing at appropriate times. Additionally, donor eligibility determinations were made despite testing being performed outside required timeframes.
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ID · 5ca5084c-0620-4637-8211-a004145e7bd0
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