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

Source: https://www.keypedia.com/records/483/great-lakes-neurotechnologies-inc/2727ce02-cb68-43a8-a814-836582a348a0

> FDA 483 for Great Lakes Neurotechnologies Inc on March 12, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Great Lakes Neurotechnologies Inc
- Inspection Date: 2026-03-12
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: 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.

## Related Documents

- [483 - 2018-09-13](https://www.keypedia.com/records/483/great-lakes-neurotechnologies-inc/a0634290-b6cb-4fbe-90d3-e30d8a6eacc3)

## Related Officers

- [Investigator ](https://www.keypedia.com/people/laureen-m-geniusz/759a858e-e3f3-4c48-8194-9804c7ab2a7b)

Company: https://www.keypedia.com/companies/great-lakes-neurotechnologies-inc/304a39a3-d4e9-42d7-a991-d04a7b463077

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22