FDA 483 - Scott & White Medical Center- Temple Andrology Laboratory - January 08, 2020
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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.
- Inspection Date
- January 8, 2020
- Product Type
- Other
ID · ef52b546-f8c9-4fee-bf1e-c9c7d79688e4