Draeger Medical Systems, Inc. – FDA 483, Apr 12, 2013

Draegar Medical Systems, Inc. in Andover, MA, a medical device manufacturer, received a Form FDA-483 with four observations during an inspection. The observations highlight deficiencies in documenting corrective and preventive actions, inadequate document control for Design History Files, and insufficient design verification for product specifications. Additionally, the firm's quality audit procedures were found to be inadequately established regarding reaudits.