# FDA 483 - Terumo BCT, Inc. - June 26, 2008

Source: https://www.globalkeysolutions.net/records/483/terumo-bct-inc/b82ea266-566c-4344-9460-5ea5d9956a27

> FDA 483 for Terumo BCT, Inc. on June 26, 2008. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Terumo BCT, Inc.
- Inspection Date: 2008-06-26
- Product Type: device
- Office Name: Denver District Office
- Summary: Gambro BCT, Inc. in Lakewood, CO, a medical device manufacturer, was cited for deficiencies in its complaint handling procedures. The firm failed to adequately investigate complaints involving possible device failures and patient adverse events. Multiple complaints were not fully investigated to determine the root cause, failing to rule out potential performance issues with devices or materials.

## Related Documents

- [483 - 2017-08-25](https://www.globalkeysolutions.net/records/483/terumo-bct-inc/5ffe9481-6c8a-42cc-9f3b-225258218a1e)

## Related Officers

- [Debra L. Curtis](https://www.globalkeysolutions.net/people/debra-l-curtis/c27cfa32-c367-4925-843f-a98c38ca1a72)

Company: https://www.globalkeysolutions.net/companies/terumo-bct-inc/69dc8f0a-8f62-4cc3-af9f-fdceb628fe6a

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face