FDA 483 - Cosway Company, Inc. - February 24, 2023

Cosway Company, Inc. in Carson, CA, a contract manufacturer, was inspected by the FDA from February 16-24, 2023. The inspection revealed two significant issues: a lack of qualified laboratory equipment for testing OTC drug products and a failure to investigate temperature excursions in warehouses where drug products and raw materials were stored. These conditions indicate potential deficiencies in quality control and product integrity.