Med Pen Concepts, LLC

Warning LetterOpen

Amy J. Aarons President Med Pen Concepts, LLC 800 W Cummings Park Woburn , MA 01801 United StatesFEI 3015602723Issued Sep 15, 2022Center for Devices and Radiological Health

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Violations11

Issue DateSep 15, 2022

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Med Pen Concepts, LLC
Location: Amy J. Aarons President Med Pen Concepts, LLC 800 W Cummings Park Woburn , MA 01801 United States
FEI Number: 3015602723
Country: United States
Issue Date: September 15, 2022
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

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.

Med Pen Concepts, LLC FDA Warning Letter, September 15, 2022