NeuroStar Solutions Inc. – FDA EIR, Jul 10, 2013

An FDA inspection was conducted at NeuroStar Solutions Inc., an Atlanta, GA-based medical device manufacturer, on July 10, 2013. The company develops and maintains a server providing diagnostic quality medical images, classified as a Class I medical device. This was a limited Quality System Inspection Technique (QSIT) focusing solely on the Corrective and Preventive Action (CAPA) subsystem, under Compliance Program 7382.845 for medical device manufacturers. The inspection revealed no significant deviations in the firm's complaint, Medical Device Report (MDR), or recall procedures. As a result, no FDA Form 483 (Objectionable Observations) was issued. NeuroStar Solutions Inc. reported no history of complaints, CAPAs, recalls, or MDRs. The only administrative observation was a request for the company president to investigate the firm's registration status with the State of Georgia. No formal regulatory actions were required by the FDA, indicating compliance with the inspected aspects of the regulatory framework.