FDA 483 - Columbus Ctr for Repro. Endo & Infertility, LLC - July 02, 2025

The FDA inspected Columbus Center for Reproductive Endocrinology & Infertility, LLC in Columbus, GA, from July 1-2, 2025. The inspection revealed an issue with recordkeeping for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), specifically that records for anonymous oocyte donors contained their names. This indicates a potential breach in donor anonymity protocols.