FDA 483 - Kareway Product Inc - March 28, 2019

Kareway Product Inc, an OTC-Monograph Drug Distributor in Compton, CA, was cited for failing to report serious adverse events for non-prescription drugs to the FDA. The firm received numerous reports of adverse drug events between 2013 and 2018, including irritation, swelling, and infection, but did not report any of these to the agency. This indicates a significant lapse in post-market surveillance and regulatory compliance.