FDA 483 - CellSure, L3C - August 02, 2021

Cellsure, LSC, a stem cell own-label distributor in Salt Lake City, UT, was cited for significant deficiencies in donor screening, recordkeeping, product quarantine, and manufacturing controls during an FDA inspection. The firm failed to adequately screen tissue donors for communicable diseases, maintain proper records for donor eligibility, and establish complete specifications for its contract manufactured placental stem cell products. Additionally, issues were noted with warehousing procedures and the lack of a stability testing program for its distributed stem cell products.