FDA 483 - The Center for Fertility & Gynecology - March 20, 2023

An FDA inspection of The Center for Fertility & Gynecology in Tarzana, CA, a reproductive fertility center, identified one observation. The firm was cited for including donor names and personal identifying information, such as dates of birth, on accompanying records for anonymous oocyte donors. This indicates a concern regarding donor privacy and record-keeping practices for human cells, tissues, and cellular and tissue-based products (HCT/Ps).