FDA 483 - Circulatory Technology Inc. - December 04, 2019

Circulatory Technology Inc. in Oyster Bay, NY, a medical device manufacturer, was inspected by the FDA from November 6 to December 4, 2019. The inspection revealed significant deficiencies across multiple quality system areas, including failures in medical device reporting, design controls, document control, CAPA, purchasing controls, and process validation. These issues indicate a systemic lack of adherence to regulatory requirements for device manufacturing.