Endow Tissue LLC – FDA 483, May 5, 2021
Endow Tissue LLC in Carrollton, TX, an HCT/P recovery establishment, was cited for significant deficiencies during an FDA inspection. Observations included inadequate screening of placenta and umbilical cord tissue donors for communicable disease risk factors, poor record-keeping regarding personnel and dates for donor screening and tissue recovery, and undefined procedures for the acquisition and recovery of birth tissue. These issues raise concerns about the firm's compliance with current good tissue practices and the safety of its HCT/P products.
ID · dda7328e-8c9f-4354-a7e3-7f72f35f60f3
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