FDA WARNING_LETTER - Dr. Joel Kaplan Inc. - June 30, 2023

On January 8, 2024, the FDA issued a Warning Letter to Dr. Joel Kaplan Inc. (DJK) following an inspection from June 27-30, 2023. The inspection revealed that DJK, a manufacturer and distributor of sexual health enhancement medical devices, was marketing misbranded and/or unapproved devices and had significant Quality System Regulation (QSR) violations.

The devices cited for misbranding and lack of approval include the MegaVac Pump System, Metal Hand Pump System, STIMULATE: Red Light Therapy Wrap, DEEP: The Ultimate Penis Extender, and the Clitoris Enhancement System. The FDA determined these devices are intended for treating disease or other conditions, thus requiring premarket approval (PMA) or investigational device exemption (IDE) and 510(k) notification, which DJK lacked. The firm's listed product codes for some devices were also deemed incorrect based on their stated intended uses. A previous 2014 Warning Letter regarding the Clitoris Enhancement System had not been addressed.

QSR violations included failure to establish and maintain procedures for complaint handling, design history files, acceptance activities, approved supplier lists, management reviews, and quality audits. DJK's responses to the FDA 483 observations were deemed inadequate, lacking sufficient evidence of completed corrective actions.

The FDA requires DJK to take prompt action within fifteen business days to address all violations