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

Source: https://www.keypedia.com/records/483/shape-medical-systems-inc/c633a3ec-5bb3-40c4-837a-c7e2e2ddc3ca

> FDA 483 for Shape Medical Systems, Inc on July 22, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Shape Medical Systems, Inc
- Inspection Date: 2019-07-22
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: 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.

## Related Officers

- [Benjamin W. Anderson](https://www.keypedia.com/people/benjamin-w-anderson/a3c0961c-6a83-4bd7-abb8-02c5c8dd3a35)

Company: https://www.keypedia.com/companies/shape-medical-systems-inc/d2fd11a1-6767-474d-9763-6cdd6f232a13

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d