FDA 483 - Zeller Power Products, LLC - September 24, 2021

Zeller Power Products, LLC in Wallace, ID, a specification developer for medical devices, received 11 observations during an FDA inspection from September 20-24, 2021. The firm demonstrated systemic failures in establishing and maintaining fundamental quality system procedures, including design control, MDR reporting, complaint handling, and CAPA. Many of these issues were repeat observations from a previous inspection in 2018, indicating a persistent lack of compliance.