Great Lakes Neurotechnologies IncMarch 12, 2026

FDA 483 - Great Lakes Neurotechnologies Inc - March 12, 2026

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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.

Company: Great Lakes Neurotechnologies Inc
Inspection Date: March 12, 2026
Product Type: Device
Office: Cincinnati District Office
Person: Laureen M. Geniusz (Investigator )

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ID · 2727ce02-cb68-43a8-a814-836582a348a0