FDA 483 - Med Pen Concepts, LLC - January 09, 2024

Med Pen Concepts, LLC, located in Woburn, MA, underwent an FDA inspection from January 9 to January 24, 2024. The inspection revealed significant compliance issues primarily related to design verification, design validation, and corrective and preventive action (CAPA) procedures.

Key violations included the failure to adequately establish procedures for design verification and validation. Specifically, the company did not verify that design outputs met design inputs for their Plasma MD and Plasma+ devices, including critical aspects such as toxicity, biocompatibility, electrical performance, and thermal effects. Additionally, the firm did not validate verification activities for their class II medical device, the Plasma Pen, nor did they document real-world clinical evidence of device performance.

The inspection also highlighted deficiencies in the CAPA system. Med Pen Concepts failed to effectively verify and validate action plans for several CAPAs, including those related to previous FDA findings. For instance, CAPA 22-010, concerning the testing of applicator tips, lacked evidence of compliance despite being marked as effective. Similarly, CAPA 005, addressing DHR maintenance, was not fully implemented as required.

The FDA emphasized the need for Med Pen Concepts to conduct thorough internal audits to identify and rectify all quality system violations. The company is expected to address these issues promptly to ensure compliance with FDA regulations and avoid potential enforcement actions.