FDA 483 - bioMerieux, Inc. - April 10, 2017

An FDA inspection of bioMerieux, Inc. in Durham, NC, a medical device manufacturer, revealed significant deficiencies. The firm's corrective and preventive action (CAPA) procedures were found to be inadequately established, with issues in investigations and effectiveness checks. Additionally, the company failed to clearly define control over products, suppliers, and contractors, specifically regarding agreements for complaint handling and medical device reporting.