FDA 483 - Alon Medical Technology - October 16, 2024

An FDA inspection of Alon Medical Technology in Flowood, MS, an HCT/P distributor, revealed significant deficiencies in their quality system. Observations included a lack of documented review and approval for core CGTP procedures, failure to follow HCT/P receipt procedures, and the absence of periodic quality audits. Additionally, the firm failed to maintain proper documentation for facility cleaning and sanitation activities.