FDA 483 - ActiveAID Medical Solutions LLC - August 18, 2023

ActiveAID Medical Solutions LLC, a human tissue warehouse in Sabana Grande, PR, was cited for multiple Current Good Tissue Practice (CGTP) deficiencies. The inspection revealed failures in recording and maintaining HCT/P storage temperatures, not following established procedures for handling and distribution, and lacking procedures for complaint review. Additionally, core CGTP procedures were not reviewed and approved by a responsible person before implementation.