FDA 483 - I-Tanaka Dental Products LLC - November 07, 2019

Asami Tanaka Dental Enterprises, Inc. in Skokie, IL, a manufacturer of dental devices, was inspected and received a Form FDA 483 with seven observations, three of which were repeat observations. The inspection revealed significant deficiencies in the firm's quality system, including failures in design history file establishment, device history records, corrective and preventive actions, supplier controls, medical device reporting procedures, device master records, and acceptance activities. These issues indicate a broad lack of adherence to medical device quality system regulations.