FDA 483 - Scott & White Medical Center- Temple Andrology Laboratory - January 08, 2020

An FDA inspection of Scott & White Memorial Hospital Andrology Laboratory in Temple, TX, revealed multiple deficiencies related to donor screening, testing, and eligibility determination for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The facility failed to adequately screen and test donors for communicable diseases, use FDA-licensed tests, collect specimens at appropriate times, and establish proper procedures for donor eligibility and HCT/P release. These observations highlight significant concerns regarding the safety and quality controls for reproductive HCT/Ps.