FDA 483 - Med Pen Concepts, LLC - January 24, 2024

An FDA 483 was issued to Med Pen Concepts, LLC following an inspection from January 9 to January 24, 2024. The document details significant deficiencies in the company's quality management system for its Plasma Pen medical devices, indicating non-compliance with current Good Manufacturing Practice (cGMP) regulations. Key observations include pervasive failures in design control, specifically inadequate design verification for critical components like power banks, applicator tips, and biocompatibility, as well as a complete lack of design validation for their Class II medical device prior to commercial distribution. The firm also demonstrated systemic issues with its Corrective and Preventive Action (CAPA) system, where actions were not effectively verified or validated, and many CAPAs remained open past due dates, some stemming from prior FDA inspections. Device History Records (DHRs) were incomplete, lacking essential manufacturing and identification details, and finished devices were released without proper final acceptance testing, including for power and frequency parameters. Further issues involved the absence of documented acceptance for incoming critical components, a lack of procedures for in-process acceptance, and a failure to establish change notification agreements with major suppliers. The risk analysis was found to be inadequate due to unjustified risk classifications and ambiguous rating definitions. Additionally, sampling plans for design verification lacked statistical justification, the cleaning procedure for reusable devices was unvalidated, and complaint handling procedures were not consistently followed. Med Pen Concepts, LLC is required to address these serious deviations to ensure their quality system meets regulatory standards, particularly concerning product design, validation, and control throughout the manufacturing and distribution process.