FDA 483 - St Luke's Hospital Assisted Reproductive Technology Lab - August 18, 2021

St Luke's Hospital Assisted Reproductive Technology Lab in Chesterfield, MO, was inspected regarding its reproductive HCT/P operations. The inspection revealed multiple significant issues related to donor eligibility, including inadequate testing and screening for communicable diseases, failure to retest donors, and insufficient quarantine procedures for HCT/Ps. Several of these conditions were noted as repeated objectionable conditions from previous inspections, indicating a persistent lack of compliance.