FDA 483 - Reproductive Services Of Indiana, Inc - January 20, 2023

Reproductive Services Of Indiana, Inc. in Carmel, IN, a reproductive facility, was inspected by the FDA. The inspection revealed that records for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) included the first names of anonymous oocyte donors. This indicates a lapse in maintaining donor anonymity within the firm's record-keeping practices.