FDA 483 - CellSure, L3C - December 08, 2023
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An FDA inspection of Cellsure, L3C in Salt Lake City, UT, a stem cell own-label distributor, revealed significant deficiencies in their handling of human placenta and umbilical cord tissue. The firm failed to properly label HCT/Ps positive for communicable diseases, lacked adequate donor screening procedures, and had not established essential quality control, warehousing, distribution, or stability testing programs. Several of these critical issues were repeat observations, indicating persistent non-compliance.
ID · 407a6b6a-0e0a-4c9b-a366-207c155e5fc4