Natus Medical Incorporated – FDA Warning Letter, Sep 10, 2014

An FDA inspection of Natus Medical Incorporated in Seattle, Washington, from August 19 to September 10, 2014, revealed that their neoBLUE LED Phototherapy devices are adulterated and misbranded. The devices, including neoBLUE, neoBLUE 2, and neoBLUE 3 systems, were found to be non-conformant with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to verify device design (21 CFR 820.30(f))**: Replacement LED Board Kits for neoBLUE 2 exceeded established irradiance parameters after an Engineering Change Order (ECO 10967) in November 2011. The firm's response regarding an engineering review checklist was deemed inadequate as it didn't ensure design output met design input. 2. **Failure to control design changes (21 CFR 820.30(i))**: The firm did not establish a validation plan for the neoBLUE 2 Replacement LED Board Kit design change, and the change in light intensity was not identified as significant, despite internal procedures requiring QA/RA and Engineering review. The draft validation procedure was also inadequate. 3. **Incomplete Design History File (DHF) (21 CFR 820.30(j))**: The neoBLUE 3 system DHF lacked design reviews. The firm