FDA 483 - OU Health - October 28, 2024

An FDA inspection of OU Health, an HCT/Ps manufacturer in Oklahoma City, revealed a significant compliance issue regarding donor eligibility documentation. The firm failed to ensure that HCT/Ps were accompanied by a statement confirming donor eligibility was based on screening and testing results. Specifically, their 'HPC Donor Eligibility / Suitability Summary Record' did not explicitly state that eligibility decisions were derived from a review of screening and testing outcomes.