FDA 483 - InControl Medical, LLC - August 21, 2012

InControl Medical, LLC, a medical device manufacturer in Brookfield, WI, was inspected by the FDA from August 14-21, 2012. The inspection revealed significant deficiencies across its quality system, including inadequate organizational structure, lack of quality audits, and widespread issues with design controls, device records, process validation, training, and document control for its InTone medical device. These observations indicate a fundamental failure to establish and maintain a compliant quality system.