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

Reproductive Technologies, Inc. in Berkeley, CA, was inspected from November 14-18, 2024. The inspection revealed that HCT/P donors were not determined to be eligible based on the results of donor screening and testing. Specifically, a directed donor was deemed eligible and their semen distributed despite a positive response to a screening question about UK travel between 1980-1996.