FDA 483 - ImpactOrtho Inc Hawaii - February 28, 2019

Spon-stek Medical Inc, Hawaii, was inspected for HCT/P storage and distribution and received a Form 483 with three observations. The firm failed to establish and maintain a quality program and appropriate procedures for HCT/P manufacturing steps. Significant issues were noted with inventory control, including missing HCT/Ps and a lack of temperature monitoring records for storage areas.