483
Neurolumen LLCFDA 483 - Neurolumen LLC - September 24, 2025
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Record Details
An FDA inspection of Neurolumen LLC, a manufacturer of the Class II medical device Neurolumen PN-1000, revealed significant deficiencies in its quality system. The firm received three repeat observations concerning inadequate procedures for purchasing, complaint handling, and document control. These issues indicate a persistent failure to establish and implement essential quality management processes.
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ID · 965702a6-289b-4a32-8d47-823e87cfbc9f