# FDA 483 - LivaNova Deutschland GmbH - April 28, 2022

Source: https://www.keypedia.com/records/483/livanova-deutschland-gmbh/ea77f1fe-c32d-4bd6-ac1b-757cd4d2020b

> FDA 483 for LivaNova Deutschland GmbH on April 28, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LivaNova Deutschland GmbH
- Inspection Date: 2022-04-28
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: LivaNova Deutschland GmbH, a medical device manufacturer in Munich, Germany, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to adequately establish design validation procedures for its Heater-Cooler System 3T, including insufficient testing of updated Instructions for Use following recalls. Additionally, the disinfection process for the device was not adequately validated, and complaints involving device failures were not investigated as required.

## Related Documents

- [483 - 2015-08-27](https://www.keypedia.com/records/483/livanova-deutschland-gmbh/ec892583-b473-4a42-bcd3-dd515c12e0d1)

## Related Officers

- [Thai T. Duong](https://www.keypedia.com/people/thai-t-duong/59737092-2f30-43a7-b23b-36fa7f212c4a)

Company: https://www.keypedia.com/companies/livanova-deutschland-gmbh/8b402140-655c-4017-9499-cb3e04ece46e

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd