FDA 483 - GWR Medical, Inc. - July 16, 2025

During an inspection conducted from July 15-16, 2025, the U.S. Food and Drug Administration (FDA) issued a Form FDA-483 to GWR Medical, Inc., a medical device specification developer in Chadds Ford, PA. The inspection revealed several significant observations indicating deficiencies in the firm's quality system, demonstrating a lack of adherence to regulatory compliance.

Key issues identified include the absence of a complete design history file for the O2Sleeve, a Class II device launched in March 2022, meaning critical documentation demonstrating its safety and effectiveness was unavailable. Furthermore, GWR Medical, Inc. failed to perform internal quality audits or maintain audit schedules from 2019 to June 2025, an observation previously noted in a 2018 inspection. The company also demonstrated inadequate control over its supply chain, specifically failing to conduct required audits of a critical supplier since July 2018. Lastly, there were no records to show that management with executive responsibility regularly reviewed the suitability and effectiveness of the quality system between 2019 and June 2025, as mandated by their own procedures.

In response to these findings, GWR Medical, Inc. committed to addressing and correcting all observations. These actions are crucial for ensuring the firm's compliance with established quality system requirements for medical devices.