# FDA 483 - Evergreen Orthopedic Research Lab, LLC dba Xpertiv - April 12, 2019

Source: https://www.globalkeysolutions.net/records/483/evergreen-orthopedic-research-lab-llc-dba-xpertiv/932db06f-04e9-440d-956a-0464905ddb88

> FDA 483 for Evergreen Orthopedic Research Lab, LLC dba Xpertiv on April 12, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Evergreen Orthopedic Research Lab, LLC dba Xpertiv
- Inspection Date: 2019-04-12
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Evergreen Orthopedic Research Lab, LLC dba Xpertiv in Kirkland, WA, a manufacturer of orthopedic accessory devices, revealed significant deficiencies in its quality system. The firm failed to adequately establish procedures for complaint handling and medical device reporting, including a lack of documentation for MDR evaluations and untimely processing of complaints. Additionally, the company used unapproved forms for documenting on-site supplier audits, indicating a breakdown in supplier control procedures.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/christopher-s-genther/e71df42c-9adf-4a78-93e5-c364dcc06b35)

Company: https://www.globalkeysolutions.net/companies/evergreen-orthopedic-research-lab-llc-dba-xpertiv/5ca6426f-2ea8-48bb-a37c-4dd3db0987cd

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822