FDA 483 - Shape Medical Systems, Inc - July 22, 2019

An FDA inspection of Shape Medical Systems, Inc. in Saint Paul, MN, a medical device manufacturer, revealed that procedures for corrective and preventive action (CAPA) were not adequately established. The firm initiated CAPAs in 2014 for its Shape-HF system analyzer due to customer complaints, but these were closed without fully implementing long-term solutions, leading to continued issues. This indicates a significant deficiency in the firm's quality system regarding complaint handling and CAPA effectiveness.