# FDA 483 - Mighty Oak Medical - May 09, 2025

Source: https://www.keypedia.com/records/483/mighty-oak-medical/b746b785-05dc-435c-b708-40b6c97dca8a

> FDA 483 for Mighty Oak Medical on May 09, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mighty Oak Medical
- Inspection Date: 2025-05-09
- Product Type: device
- Office Name: Denver District Office
- Summary: Mighty Oak Medical, Inc. in Englewood, CO, a medical device manufacturer, was cited with two observations on a Form FDA 483. The inspection revealed inadequate procedures for equipment calibration, specifically concerning out-of-tolerance measurements and traceability to standards. Additionally, the firm failed to properly control nonconforming products by not including non-conformance records in the finished product Device History Record.

## Related Officers

- [investigator](https://www.keypedia.com/people/matthew-m-vernon/f77e8c18-8614-49e3-9b19-3327b7fe7648)

Company: https://www.keypedia.com/companies/mighty-oak-medical/89c8a0f3-2b3a-4f33-bfe1-34f5c9eea05b

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