FDA 483 - ImpactOrtho Inc - February 06, 2025

ImpactOrtho Inc, an HCT/P distributor in Tempe, AZ, was cited for significant deficiencies in its quality program and equipment maintenance during an FDA inspection. The firm failed to record and maintain temperature records for HCT/P products and ambient products, and distributed products without proper temperature monitoring. Additionally, the firm lacked procedures for investigating temperature alarms and failed to perform required equipment qualifications and alarm checks for freezers storing HCT/Ps.