FDA 483 - Lucile Salter Packard Children's Hospital Stanford Medicine Fertility and Reproductive Health - April 27, 2023

An FDA inspection of Lucile Salter Packard Children's Hospital Stanford Medicine Fertility and Reproductive Health in Sunnyvale, CA, identified a critical issue with communicable disease testing. The firm failed to adhere to manufacturer's instructions for collecting urine specimens from reproductive cell and tissue donors. This non-compliance involved incorrect urine volumes and collection methods, potentially compromising the sensitivity of tests for Chlamydia trachomatis and Neisseria gonorrhea.