FDA 483 - Unetixs Vascular, Inc. - June 11, 2018

OneLuxe Vascular Inc., a manufacturer in North Kingstown, RI, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to establish adequate procedures for corrective and preventive actions, properly investigate device complaints, and ensure timely review of service records. All three observations were repeats, indicating persistent non-compliance with regulatory requirements.