# FDA 483 - Terumo Cardiovascular Systems Corp - January 17, 2013

Source: https://www.globalkeysolutions.net/records/483/terumo-cardiovascular-systems-corp/774c09df-9f82-4add-bf13-cb1fabcaaa4e

> FDA 483 for Terumo Cardiovascular Systems Corp on January 17, 2013. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Terumo Cardiovascular Systems Corp
- Inspection Date: 2013-01-17
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Terumo Cardiovascular Systems Corp in Ashland, MA, a manufacturer and repacker/relabeler of medical devices, revealed three significant observations. The firm failed to adequately maintain device history records, establish proper labeling control procedures, and implement corrective and preventive action procedures. These issues indicate deficiencies in the firm's quality system regarding documentation and complaint handling.

## Related Documents

- [483 - 2017-09-25](https://www.globalkeysolutions.net/records/483/terumo-cardiovascular-systems-corp/c4479304-b394-414c-a47c-7694f1377d51)

## Related Officers

- [Cameron E. Moore](https://www.globalkeysolutions.net/people/cameron-e-moore/5a879539-24b7-4c54-99e4-b8e31f18ec9b)

Company: https://www.globalkeysolutions.net/companies/terumo-cardiovascular-systems-corp/7141c116-e93e-4ebf-bb9e-a06e03d3bc48

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7