FDA 483 - Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. - February 15, 2019

An FDA inspection of Polymer Technology Systems, Inc. in Indianapolis, IN, a medical device manufacturer, revealed significant quality system deficiencies. The firm failed to adequately validate processes and designs, maintain effective corrective and preventive actions, and ensure proper supplier controls. Additionally, the company did not submit required Medical Device Reports for serious malfunctions, including battery explosions, and lacked proper health impact assessments for product corrections.