Repro Lab, Inc. – FDA 483, Oct 16, 2020

Repro Lab in New York was cited for significant deficiencies in its HCT/P donor eligibility determination processes during an FDA inspection. The firm failed to adequately screen donors for communicable disease risks like ZIKV, maintain accurate donor records, and establish comprehensive screening procedures. These issues led to the distribution of HCT/Ps from potentially ineligible donors.