483
Mobius Bionics, LLCMobius Bionics, LLC – FDA 483, Nov 16, 2022
Record Details
An FDA inspection of Mobius Bionics, LLC in Manchester, NH, conducted from November 10-16, 2022, identified one observation. The firm failed to conduct management reviews of its quality system at defined intervals, as required by its own procedures. This indicates a lapse in oversight of the quality system for their Class II medical device.
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ID · 37a18b70-7ce4-4813-9a4a-4628d3335f41
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