# FDA 483 - McGinley Orthopaedic Innovations LLC - June 05, 2025

Source: https://www.keypedia.com/records/483/mcginley-orthopaedic-innovations-llc/f76e1efd-a7b3-4bee-823a-1c61f0a9d946

> FDA 483 for McGinley Orthopaedic Innovations LLC on June 05, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: McGinley Orthopaedic Innovations LLC
- Inspection Date: 2025-06-05
- Product Type: device
- Office Name: Denver District Office
- Summary: McGinley Orthopaedic Innovations LLC in Casper, WY, was inspected by the FDA from June 3-5, 2025. The inspection revealed that the firm's procedures for ensuring equipment is routinely calibrated and checked were not adequately established. This included having five tools with expired calibrations in service and failing to follow its own procedure for a passivation process by lacking necessary controls and a known solution.

## Related Officers

- [Clifford F. Long](https://www.keypedia.com/people/clifford-f-long/846e5a0c-cb7c-421c-86aa-be9fddfbaaba)

Company: https://www.keypedia.com/companies/mcginley-orthopaedic-innovations-llc/5f0312fa-cd7c-4b57-85a8-257b14728e7b

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face