FDA 483 - Control Solutions, LLC. - September 15, 2022

An FDA inspection of Control Solutions, LLC. in Aurora, IL, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm lacked written procedures for Medical Device Reporting and device history records, and failed to maintain complete design control files and validate software used for final acceptance testing of their Class 2 medical devices. Additionally, personnel training documentation was found to be missing.