SDI Diagnostics, Inc. – FDA 483, Sep 30, 2021

SDI Diagnostics, Inc. in South Easton, MA, was inspected regarding its manufacturing operations. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for acceptance activities, equipment calibration, corrective and preventive actions, complaint handling, and supplier controls. These observations indicate a need for comprehensive improvements in the firm's quality management system.