Medicol USA Inc. – FDA 483, Sep 12, 2019

Medicol USA Incorporated, a medical device manufacturer in Los Gatos, CA, was inspected by the FDA from September 10-12, 2019. The inspection revealed significant deficiencies in the firm's quality system, including a lack of established procedures for quality policy, CAPA, non-conforming product, management review, and the absence of quality audits and documented management review results. These observations indicate a fundamental breakdown in the firm's quality management system.