FDA 483 - Rymed Technologies, LLC - June 24, 2022

Rymed Technologies, LLC in Austin, TX, a medical device specification developer, was cited for significant deficiencies during an FDA inspection. The firm failed to submit Medical Device Reports (MDRs) within the required timeframe for device malfunctions, specifically weld failures in their InVision-Plus IV Connector, which led to patient injury and required medical intervention. Additionally, the company's corrective and preventive action (CAPA) procedures were found to be inadequate, failing to properly analyze recurring quality problems.