483
Reproductive Technologies, Inc.Reproductive Technologies, Inc. – FDA 483, Nov 18, 2024
Record Details
An FDA inspection of Reproductive Technologies, Inc. in Berkeley, CA, from November 14-18, 2024, revealed a significant deficiency in donor eligibility determination. The firm failed to properly screen and test HCT/P donors, specifically distributing semen from a donor who reported extensive travel to the UK during a period associated with CJD risk. This indicates a serious lapse in donor screening protocols.
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ID · 17dd402d-e532-4072-8270-7fee3c51c869
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