FDA 483 - Reflexonic, LLC - April 19, 2016

Reflexonic, LLC, a medical device manufacturer in Frederick, MD, was inspected by the FDA from April 4-19, 2016. The inspection revealed nine significant observations primarily related to inadequate quality system procedures, including issues with design control, complaint handling, corrective and preventive actions, non-conformance control, distribution records, and personnel training. These findings indicate a systemic lack of established and followed procedures for ensuring device quality and regulatory compliance.