FDA 483 - Alon Medical Technology - March 08, 2022

Alon Medical Technology in Metairie, LA, a tissue distributor, received a Form 483 with five observations primarily related to inadequate documentation and procedural controls for human cells, tissues, and cellular and tissue-based products (HCT/Ps). The inspection revealed issues with unverified procedures, lack of review and approval for core procedures, insufficient documentation of corrective actions for storage conditions, incomplete HCT/P receipt records, and absence of facility cleaning records. These findings indicate significant deficiencies in the firm's quality system and adherence to current good tissue practices (CGTP).