# FDA 483 - Terumo Cardiovascular Systems Corp - September 25, 2017

Source: https://www.globalkeysolutions.net/records/483/terumo-cardiovascular-systems-corp/c4479304-b394-414c-a47c-7694f1377d51

> FDA 483 for Terumo Cardiovascular Systems Corp on September 25, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Terumo Cardiovascular Systems Corp
- Inspection Date: 2017-09-25
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Terumo Cardiovascular Systems Corp in Ashland, MA, a manufacturer of Cardiovascular Procedure Kits, identified two significant observations. The firm was cited for inadequate complaint file maintenance, specifically lacking defined processing timeframes and having complaints open for extended periods. Additionally, the inspection found deficiencies in establishing and adhering to equipment preventative maintenance schedules for critical sealing equipment.

## Related Documents

- [483 - 2013-01-17](https://www.globalkeysolutions.net/records/483/terumo-cardiovascular-systems-corp/774c09df-9f82-4add-bf13-cb1fabcaaa4e)

## Related Officers

- [Nabil Nakhoul](https://www.globalkeysolutions.net/people/nabil-nakhoul/d676e9c9-566c-4e59-84e8-1dc474e4e48d)

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