# FDA 483 - LivaNova Deutschland GmbH - August 27, 2015

Source: https://www.keypedia.com/records/483/livanova-deutschland-gmbh/ec892583-b473-4a42-bcd3-dd515c12e0d1

> FDA 483 for LivaNova Deutschland GmbH on August 27, 2015. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LivaNova Deutschland GmbH
- Inspection Date: 2015-08-27
- Product Type: device
- Office Name: Division of Advertising & Promotion 
- Summary: The FDA inspected Sorin Group Deutschland GmbH in Munchen, Germany, a medical device manufacturer, from August 24-27, 2015. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning the inadequate validation of disinfection processes for their Heater-Cooler System 3T, which had been linked to Mycobacterium chimaera contamination. Additionally, the firm lacked adequately established procedures for validating new manufacturing processes.

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## Related Officers

- [investigator](https://www.keypedia.com/people/laiza-v-garcia/d24e0890-a153-4d8a-9c74-2cc2f2773192)

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

Office: https://www.keypedia.com/offices/division-of-advertising-promotion/adcc8282-aca9-4610-955c-e6553c7619b0