FDA 483 - THEWEB2U.COM, LLC - July 30, 2019

The Web 2U Com LLC, a medical device specification developer, repacker, and relabeler in Fort Lauderdale, FL, was cited for multiple quality system deficiencies during an FDA inspection. The firm failed to establish and adequately maintain procedures for critical areas such as design control, document control, acceptance activities, purchasing controls, medical device reporting, device master records, statistical techniques, and device history records. These observations indicate a systemic lack of compliance with regulatory requirements for medical device manufacturing and quality management.