FDA 483 - Diamond Wipes International, Inc. - September 06, 2019

An FDA inspection of Diamond Wipes International, Inc. in Chino, CA, a medical device manufacturer, revealed two significant observations. The firm failed to establish adequate procedures for evaluating suppliers of bulk class II medical device products and for executing quality agreements with these suppliers. Additionally, the company lacked comprehensive written Medical Device Reporting (MDR) procedures to ensure timely and effective reporting of adverse events.