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

The FDA issued a Warning Letter to Med Pen Concepts, LLC for violations observed during an inspection from April 5-13, 2022, at their Woburn, MA facility. The firm manufactures "Plasma MD" and "Plasma +" devices, which the FDA determined are medical devices based on claims of affecting body structure/function.

The devices were found to be adulterated under Section 501(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). Specific QS violations include: 1. Failure to adequately establish and maintain procedures for design changes (21 CFR § 820.30(i)), specifically regarding changes to plasma pen tips (sterile to non-sterile, new manufacturer) without proper documentation or validation. 2. Failure to establish and maintain procedures for corrective and preventive actions (CAPA) (21 CFR § 820.100(a)), as a power control improvement was not documented per the CAPA procedure. 3. Failure to adequately establish and maintain procedures for complaint handling (21 CFR § 820.198), with 17 complaints since September 2019 not documented using the required electronic form, and lacking essential information. 4. Failure to adequately establish and maintain procedures for incoming product acceptance (21 CFR § 820.80(b)),