Apical Instruments Inc – FDA 483, Feb 13, 2020

Pascal Instruments Inc in Redwood City, CA, was inspected by the FDA from February 10-13, 2020. The inspection revealed significant deficiencies in quality system procedures, including inadequate control of non-conforming products, insufficient equipment verification, poor documentation of acceptance activities, and a lack of proper employee training. These issues indicate a moderate level of non-compliance with medical device quality system regulations.