# FDA 483 - LivaNova USA Inc. - March 26, 2013

Source: https://www.keypedia.com/records/483/livanova-usa-inc/d46de8d2-a87a-4a3c-a480-5ad5c267539b

> FDA 483 for LivaNova USA Inc. on March 26, 2013. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LivaNova USA Inc.
- Inspection Date: 2013-03-26
- Product Type: device
- Office Name: Denver District Office
- Summary: Sorin Group USA, Inc. in Arvada, CO, was inspected from March 19-26, 2013, revealing significant deficiencies in their design control processes. The firm failed to validate the design of the EasyFlow Duo Cannula with Guidewire under defined operating conditions, lacking proper protocols and sample identification. Additionally, design verification documentation was inadequate, failing to confirm that design output met input requirements, with issues such as missing statistical rationale, raw data, and calibration information.

## Related Documents

- [483 - 2008-07-25](https://www.keypedia.com/records/483/livanova-usa-inc/a5f0c3c2-8c16-4b75-b1a4-ed8ec2285268)

## Related Officers

- [Amanda S. Zorn](https://www.keypedia.com/people/amanda-s-zorn/b633fc9d-b511-45ed-a5ac-8b764420352c)

Company: https://www.keypedia.com/companies/livanova-usa-inc/4c8872e9-2e3c-4048-b29d-a5b9ede8e969

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