483
Great Lakes Neurotechnologies IncGreat Lakes Neurotechnologies Inc – FDA 483, Mar 12, 2026
Record Details
An FDA inspection of Great Lakes Neurotechnologies Inc, a medical device manufacturer in Independence, OH, revealed significant deficiencies in their risk management record-keeping. The firm's Risk Assessment for Kinesia Family of products was found to be inadequately maintained, lacking documented risk control measures and clear mitigation activities. This indicates a serious lapse in ensuring product safety and compliance with established procedures.
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ID · 2727ce02-cb68-43a8-a814-836582a348a0
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