FDA 483 - HealthCare Products, Inc. - August 30, 2019

HealthCare Products, Inc. in Coldwater, OH, a manufacturer, relabeler, and repackager, was cited with five observations during an FDA inspection. The inspection revealed a systemic lack of established or adequately established procedures across critical quality system areas, including quality audits, complaint handling, nonconforming product control, purchasing controls, and device history records. This indicates significant deficiencies in the firm's quality management system.