FDA 483 - Acme United Corporation - March 13, 2020

Acme United Corporation, a repacker/relabeler of first aid convenience kits and Class II CPR masks in Vancouver, WA, was inspected by the FDA. The inspection revealed multiple deficiencies in their quality system, including inadequate procedures for complaint handling, control of nonconforming product, equipment calibration, device history records, and purchasing controls. These issues indicate a systemic failure to adequately establish and implement required quality procedures.