FDA 483 - Aggredyne, Inc. - April 14, 2022

Aggredyne, Inc. in Houston, TX, a medical device manufacturer, was inspected by the FDA from March 29 to April 14, 2022. The inspection revealed significant deficiencies across multiple quality system areas, particularly concerning design control, software validation, corrective and preventive actions, complaint handling, and servicing procedures for their AggreGuide A-100 medical devices. These issues indicate a systemic lack of adherence to established procedures and regulatory requirements, with several observations being repeat findings from a previous inspection.