FDA 483 - Northgate Technologies, Inc. - April 19, 2022

An FDA inspection of Northgate Technologies, Inc. in Elgin, IL, a medical device manufacturer, identified one observation. The firm failed to adequately establish procedures for servicing activities and verifying that servicing meets specified requirements. This included allowing an unqualified customer in Japan to perform servicing and repairs on their Class 2 Nebulae I System.