FDA 483 - Mighty Oak Medical - May 09, 2025

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.