Dot International – FDA 483, Feb 26, 2019

Dot International, a manufacturer and repackager/relabeler in Evanston, IL, was cited with nine observations during an FDA inspection. The firm failed to establish and maintain numerous critical quality system procedures, including design controls, product quality definition, supplier evaluation, incoming product acceptance, device master and history records, corrective and preventive actions, and complaint handling. Additionally, the firm lacked written Medical Device Reporting (MDR) procedures and did not assess complaints for MDR reportability.