FDA 483 - ARP Wave L.L.C. - December 06, 2021

ARF Wave L.L.C. in Apple Valley, MN, a medical device relabeler, was cited for numerous fundamental quality system deficiencies during an FDA inspection. The firm lacked established procedures for complaint handling, medical device reporting (MDR), corrective and preventive actions (CAPA), supplier control, acceptance activities, and document control. These observations indicate a severe absence of documented and implemented quality system processes.