PJM World Wide LLC – FDA 483, Nov 4, 2024

PJM World Wide LLC, a specification developer in Doral, FL, was cited for numerous significant deficiencies in its quality system for Class II medical devices during an FDA inspection. The firm failed to establish fundamental procedures for complaint handling, design control, supplier management, servicing, acceptance activities, Medical Device Reporting (MDR), corrective and preventive actions (CAPA), document control, and overall quality system management. Additionally, the firm's medical device labels lacked Unique Device Identifiers (UDI), and required information was not submitted to the Global Unique Device Identifier Database (GUDID).