FDA 483 - Alan Neuromedical Technologies - September 13, 2018

During an inspection conducted from September 10-13, 2018, the Food and Drug Administration (FDA) issued a Form FDA 483 to Alan Neuromedical Technologies, a medical device specification developer located in The Woodlands, TX. The inspection revealed three significant observations indicating non-compliance with established quality system requirements for medical devices.

The primary issues included a failure to adequately evaluate and qualify potential suppliers, specifically the contract manufacturer for their VECTTOR VT-200 device, which contradicted the company’s own procedures. Additionally, complaint files were not adequately maintained, as the firm neglected to complete required Medical Device Report (MDR) checklists for several customer complaints, a critical step for assessing potential adverse events. Finally, the company failed to conduct internal quality audits for multiple years (2013, 2014, 2015, and 2017) since the device's distribution began in 2012, which is a fundamental component of an effective quality system.

These observations highlight deficiencies in the company's adherence to its documented procedures and the broader regulatory framework governing medical device quality systems. Alan Neuromedical Technologies acknowledged these findings and committed to implementing corrective actions for each identified issue to address these compliance gaps.