FDA 483 - Micro Therapeutics, Inc. - September 17, 2021

Micro Therapeutics, Inc. in Irvine, California, a medical device manufacturer, was inspected and received a Form FDA 483 with six observations indicating significant quality system deficiencies. The inspection revealed failures in controlling non-conforming product, design change procedures, supplier management, product control, corrective and preventive actions, and employee training, which collectively led to multiple Class I product recalls. The findings suggest systemic issues in maintaining product quality and regulatory compliance.