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

Source: https://www.keypedia.com/records/483/arp-wave-llc/2db208be-0837-4ae3-aa37-dd0c0768da22

> FDA 483 for ARP Wave L.L.C. on December 06, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ARP Wave L.L.C.
- Inspection Date: 2021-12-06
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: 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.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/joseph-d-gong/c1079a56-5f84-4e0d-9f76-9dc1187e588a)

Company: https://www.keypedia.com/companies/arp-wave-llc/c61e4468-8906-4bfe-82f8-ad0555a01946

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d