FDA 483 - MILESMAN S.L. - February 12, 2016

MILESMAN S.L. in Gijon, Spain, was inspected by the FDA, revealing significant deficiencies in its quality system. The inspection found inadequate procedures for nonconformance handling, complaint evaluation, and corrective and preventive actions. Additionally, issues were noted with device history records, management review of the quality system, and the failure to submit required annual reports for their Milesman Premium Laser System.