Shape Medical Systems, Inc – FDA 483, Jul 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.
- Person
ID · c633a3ec-5bb3-40c4-837a-c7e2e2ddc3ca
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.