483
Neuromechanical Innovations, LLCNeuromechanical Innovations, LLC – FDA 483, Dec 13, 2023
Record Details
Neuromechanical Innovations, LLC, a medical device manufacturer in Chandler, AZ, was cited for significant deficiencies during an FDA inspection. The firm failed to include unique device identifiers (UDI) on medical device labels for its Impulse/Impulse iQ adjustment tools. Additionally, the company had not conducted required management reviews or quality audits for the past two years, indicating a lapse in quality system oversight.
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ID · 8bac68db-c3ca-41cd-8226-28107560a288
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