FDA 483 - St Luke's Hospital Assisted Reproductive Technology Lab - August 18, 2021
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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.
- Inspection Date
- August 18, 2021
- Product Type
- Biologics
ID · 5e951df9-155f-413a-8152-1b5c53f73919