FDA 483 - Great Lakes Neurotechnologies Inc - September 13, 2018

An FDA inspection conducted at Great Lakes Neurotechnologies Inc., a medical device manufacturer located in Cleveland, OH, from September 5-13, 2018, identified significant concerns with the company's quality system. The inspection, documented in an FDA Form 483, highlighted two primary observations.

Firstly, the company's procedures for managing non-conforming products were deemed inadequate. Specifically, non-routine rejected parts lacked proper investigation, and there was no clear process for initiating and managing supplier corrective actions, despite instances requiring such measures.

Secondly, design input requirements for the Kinesia 360 device were found to be insufficient. The observations included missing, incomplete, or ambiguous design inputs, discrepancies between stated requirements and testing parameters (e.g., temperature ranges), and the omission of key product features advertised in marketing materials from the documented design inputs. This indicates a failure to ensure requirements are adequate, clear, complete, and unambiguous, as per the company's own procedures.

These issues fall under the regulatory framework governing medical device quality systems. Great Lakes Neurotechnologies Inc. is required to address these deficiencies to ensure compliance with federal regulations. The company has formally promised to correct both observations.