FDA 483 - AcroMetrix - October 20, 2014

During an inspection, AcroMetrix, a medical device manufacturer in Benicia, CA, was cited for deficiencies in its design history file and design control procedures. Specifically, the firm failed to demonstrate that design was developed following regulatory requirements, including issues with design reviews and the verification/validation of device labeling. These findings indicate a lack of adherence to quality system regulations for medical device design.