FDA 483 - Reproductive Technologies, Inc. - November 18, 2024

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.