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Med Pen Concepts, LLC manufactured and marketed "Plasma MD" and "Plasma +" devices intended to improve skin appearance by stimulating collagen production, which the FDA determined were medical devices subject to Current Good Manufacturing Practice (CGMP) and Quality System Regulation (QSR) requirements. During an FDA inspection conducted in April 2022, investigators found that the company was operating these devices without proper regulatory compliance, as evidenced by non-compliant product labeling, marketing claims, and manufacturing practices documented on their website and product materials. The company failed to meet CGMP/QSR obligations for medical device manufacturing, resulting in the products being deemed adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act.