483
Zeller Power Products, LLCZeller Power Products, LLC – FDA 483, Sep 24, 2021
Record Details
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.
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ID · 25dc843e-2a93-42df-8a31-18c9feb40968
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