# FDA 483 - Terumo Cardiovascular Systems Corporation - December 16, 2022

Source: https://www.keypedia.com/records/483/terumo-cardiovascular-systems-corporation/de87d008-9b5c-49a2-9f1c-606f90a13266

> FDA 483 for Terumo Cardiovascular Systems Corporation on December 16, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Terumo Cardiovascular Systems Corporation
- Inspection Date: 2022-12-16
- Product Type: device
- Office Name: Office of Regulatory Affairs
- Summary: Terumo Cardiovascular Systems Corporation in Elkton, MD, a medical device manufacturer, received a Form FDA 483 with two significant observations. The inspection revealed inadequate procedures for preventing product contamination, evidenced by numerous foreign matter incidents, and deficiencies in their customer complaint handling process. These issues indicate a need for improved quality system controls.

## Related Officers

- [Jude C. Dike](https://www.keypedia.com/people/jude-c-dike/ea760122-1121-420a-9875-c49de6f3bb0e)

Company: https://www.keypedia.com/companies/terumo-cardiovascular-systems-corporation/5b57a52d-a9b4-4711-ba20-3070b4143f7f

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64