FDA 483 - Midwest Transplant Network - February 19, 2019

Midwest Transplant Network, an HCT/P Procurement Organization in Westwood, KS, was cited for four observations during an FDA inspection from February 5-19, 2019. The observations primarily concern inadequate controls over HCT/P recovery and storage, insufficient documentation of supplies, and failures in equipment maintenance and calibration for manufacturing and testing. These issues indicate a lack of adherence to established procedures and record-keeping, potentially impacting product quality and safety.