# FDA 483 - Devon Orthopaedic Implants LLC., - March 23, 2020

Source: https://www.globalkeysolutions.net/records/483/devon-orthopaedic-implants-llc/54cf2991-3f97-4d54-bfc0-6de4a17f1366

> FDA 483 for Devon Orthopaedic Implants LLC., on March 23, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Devon Orthopaedic Implants LLC.,
- Inspection Date: 2020-03-23
- Product Type: device
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Devon MD LLC, a Specification Developer/Initial Importer in King Of Prussia, PA, revealed significant deficiencies in their quality system. The firm failed to maintain complaint files, establish written Medical Device Reporting (MDR) procedures, and implement procedures for receiving and evaluating complaints. Additionally, the inspection found a lack of procedures for identifying products throughout all stages of their lifecycle.

## Related Documents

- [483 - 2022-05-18](https://www.globalkeysolutions.net/records/483/devon-orthopaedic-implants-llc/33c0862e-30c1-412d-9a9b-68e5bd09802e)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/dennis-r-hock/f13e2db1-b808-466d-a974-e5af2d5dfdb0)

Company: https://www.globalkeysolutions.net/companies/devon-orthopaedic-implants-llc/b241a6f0-edc5-4701-af48-671b93142909

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8