Diamond Wipes International, Inc. – FDA 483, Mar 19, 2021

An FDA inspection of Diamond Wipes International, Inc. in Chino, CA, a drug manufacturer, revealed six significant deficiencies in their operations. The firm failed to establish adequate laboratory controls, maintain complete data, ensure data integrity in computerized systems, and properly manage quality control responsibilities. Additionally, investigations into product discrepancies were insufficient, and drug product labels were not stored in a controlled area, indicating serious compliance issues, including repeat deficiencies from prior inspections.