FDA 483 - Sharplight Technologies - February 14, 2019

An FDA inspection of SharpLight Technologies, a medical device firm in Rishon le-Tsiyon, Israel, revealed significant quality system deficiencies. The firm failed to adequately establish corrective and preventive action procedures and did not properly document design review results. Additionally, SharpLight Technologies introduced several class 2 medical/class IV laser devices into U.S. commerce without submitting required product reports and annual reports to the FDA.