FDA 483 - Diamond Wipes International Inc. - March 03, 2022

Diamond Wipes International Inc. in Bucyrus, OH, an OTC manufacturer, was cited for significant deficiencies in its quality control and manufacturing processes. Observations included a lack of established control procedures for manufacturing processes, inadequate testing of in-process materials for purity and pathogens, and failure to follow written production and process control procedures. The firm also failed to properly manage changes to procedures and equipment, conduct thorough investigations into discrepancies, and qualify critical manufacturing equipment and water systems.