Unknown Company – FDA EIR, Apr 19, 2016

An FDA surveillance inspection of Reflexonic, LLC, a Class II medical device manufacturer located in Frederick, MD, was conducted from April 4 to April 19, 2016. The inspection focused on the firm's Viberect Penile Vibratory Stimulation Device, operating under the regulatory framework of 21 CFR Part 820, Quality System Regulation, for medical device manufacturers.The inspection identified nine significant observations documented on an FDA-483 form. Key issues included inadequate procedures for design validation, design verification failing to confirm output against input requirements, and insufficient design input documentation regarding product noise levels. The firm also lacked adequate corrective and preventive action (CAPA) procedures, with ineffective checks and no analysis. Complaint handling was deficient, as investigations into device failures were not consistently performed, and procedures for evaluating online customer reviews as complaints were absent. Furthermore, Reflexonic failed to control non-conforming products, such as rejected devices lacking proper reports, and did not maintain adequate distribution records for product traceability. Finally, documentation for personnel training for key roles was incomplete.In response to these findings, the company's President and CEO, Dr. Kambiz Tajkarimi, acknowledged the observations and committed to implementing the necessary corrections within 15 business days. This requires Reflexonic, LLC to revise and implement compliant quality system procedures across design controls, complaint handling, CAPA, non-conformance, distribution, and personnel training to align with regulatory requirements.