# FDA 483 - Orthofix U.S. LLC - March 17, 2023

Source: https://www.keypedia.com/records/483/orthofix-us-llc/266a0522-b819-470b-b94e-9cc39dc2af03

> FDA 483 for Orthofix U.S. LLC on March 17, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Orthofix U.S. LLC
- Inspection Date: 2023-03-17
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Orthofix U.S. LLC in Lewisville, TX, revealed significant deficiencies in their quality system. The firm failed to adequately evaluate and investigate customer complaints for their Class III AccelStim Bone Growth Stimulator, even when device failures were reported. Additionally, the company's corrective and preventive action (CAPA) procedures were not adequately established, leading to a lack of investigation into numerous device issues.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/roy-baby/69a18ef5-167c-41eb-a57e-3d138a0820c2)
- [Terri E. Gibson](https://www.keypedia.com/people/terri-e-gibson/f1a80f95-a5c4-4cae-9a4b-e23f367770bb)

Company: https://www.keypedia.com/companies/orthofix-us-llc/9fbfeb62-83aa-4916-835e-271a38d56ba9

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab