FDA 483 - Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. - September 07, 2021

Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. in Whitestown, IN, was inspected regarding its manufacturing processes for medical devices. The inspection revealed significant deficiencies in process validation, including inadequate challenging of worst-case conditions and vision system capabilities. Additionally, the firm failed to adequately establish and follow corrective and preventive action procedures for distributed devices, indicating a lack of robust quality system controls.