FDA WARNING_LETTER - Dr. Joel Kaplan Inc. - July 17, 2013

On May 1, 2014, the FDA issued a Warning Letter to Dr. Joel Kaplan, Inc. following an inspection from June 19 to July 17, 2013. The firm, operating from a retail store and websites (www.drjoelkaplan.com, www.getbiggertoday.com), manufactures and sells the MegaVac System (an external penile rigidity device) and the Clitoris Enhancement System, along with dietary supplements.

The MegaVac System was found to be adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820). Specific violations included failure to maintain device history records (21 CFR 820.184) for repacked MegaVac pumps and failure to establish complaint handling procedures (21 CFR 820.198(a)).

Furthermore, the MegaVac System was deemed adulterated under 21 U.S.C. § 351(f)(1)(B) because the firm lacked an approved premarket approval (PMA) or investigational device exemption (IDE). It was also misbranded under 21 U.S.C. § 352(o) for major changes to its intended use (e.g., penis enlargement, curvature correction) without