# FDA 483 - Terumo Cardiovascular Systems Corporation - September 28, 2012

Source: https://www.globalkeysolutions.net/records/483/terumo-cardiovascular-systems-corporation/ab62c2e6-8cca-4df8-b7db-e7bde0dd7802

> FDA 483 for Terumo Cardiovascular Systems Corporation on September 28, 2012. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Terumo Cardiovascular Systems Corporation
- Inspection Date: 2012-09-28
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Terumo Cardiovascular Systems Corporation in Ann Arbor, MI, was cited for four significant issues during an FDA inspection. The firm failed to submit premarket notifications for significant device changes, reported numerous Medical Device Reports (MDRs) late, lacked adequate procedures for broker-purchased components, and had insufficient procedures for controlling nonconforming products related to environmental monitoring deviations. These observations indicate serious deficiencies in regulatory compliance and quality system management.

## Related Documents

- [483 - 2005-12-09](https://www.globalkeysolutions.net/records/483/terumo-cardiovascular-systems-corporation/178619f8-e041-4f9e-acf9-78c150503b95)
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- [483 - 2010-03-29](https://www.globalkeysolutions.net/records/483/terumo-cardiovascular-systems-corporation/91358452-97b4-4c1b-8281-77aced3673c6)
- [483 - 2008-08-11](https://www.globalkeysolutions.net/records/483/terumo-cardiovascular-systems-corporation/b54a6646-bf21-4eb7-a0b9-364383448e24)

## Related Officers

- [Medical Device Senior Operations Officer at FDA](https://www.globalkeysolutions.net/people/thomas-a-peter/48a36892-cc03-42bb-8960-978d18f2147a)
- [Investigator](https://www.globalkeysolutions.net/people/patrick-cummings/1fce2fdc-9207-480a-bb4f-ffe7bbf65094)

Company: https://www.globalkeysolutions.net/companies/terumo-cardiovascular-systems-corporation/27d34ede-00fd-45aa-b5e4-6158781b6854

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0