FDA 483 - Med Pen Concepts, LLC - April 13, 2022

Med Pen Concepts, Llc in Woburn, MA, was inspected regarding its manufacturing operations for a plasma device. The inspection revealed significant deficiencies across its quality system, including inadequate complaint handling, lack of documented CAPA activities, and failure to establish proper procedures for design changes and acceptance activities. Additionally, the firm lacked device history records, written MDR procedures, and evidence of internal quality audits and management reviews, indicating a broad breakdown in quality system compliance.