FDA 483 - SQ Medical Supplies Inc. - June 10, 2022

SQ Medical Supplies Inc. in City of Industry, CA, was inspected by the FDA on June 8 and 10, 2022. The inspection revealed a significant deficiency related to the firm's complaint handling procedures. Specifically, the firm lacked established procedures for receiving, reviewing, and evaluating complaints, including those that may require Medical Device Reporting.