FDA 483 - DDC Technologies, Inc. - June 28, 2019

DDC Technologies Inc., a manufacturer of laser hair removal devices in Oceanside, NY, was cited for numerous quality system deficiencies during an FDA inspection. The observations primarily concerned the lack of established procedures for design control, design changes, environmental controls, equipment calibration, and quality audits. Several issues, including inadequate device history records and design change procedures, were repeat observations from a previous inspection, indicating significant and persistent non-compliance.