FDA 483 - DimcoGray Inc. - September 17, 2018

An FDA inspection of Dimco-Gray Inc., a contract manufacturer in Centerville, OH, revealed nine significant deficiencies in its quality system. The firm lacked established procedures for critical areas such as corrective and preventive actions, process validation, acceptance activities, non-conforming product control, complaint handling, environmental control, change management, quality audits, and employee training. These observations indicate a broad failure to maintain adequate controls for medical device manufacturing.