FDA 483 - Tosoh Bioscience Inc - October 16, 2018

An FDA inspection of Tosoh Bioscience Inc. in Grove City, OH, a medical device manufacturer, revealed significant deficiencies in their quality system. Observations included inadequate procedures for corrective and preventive actions, control of nonconforming product, servicing activities, and process validation. These issues indicate a lack of adherence to established quality management principles.