FDA 483 - LifeGift Organ Donation Center - Fort Worth - August 06, 2021

An FDA inspection of LifeGift Organ Donation Center - Fort Worth revealed significant deficiencies in environmental monitoring and quality program procedures for human tissue recovery. The facility failed to monitor environmental conditions in its tissue recovery suite, leading to potential contamination of HCT/Ps. Additionally, the firm lacked established procedures for core Current Good Tissue Practices (CGTP) requirements and did not effectively investigate or implement corrective actions for numerous humidity excursions.