# FDA WARNING_LETTER - Sorin Group Deutschland GmbH - September 01, 2015

Source: https://www.keypedia.com/records/warning_letter/sorin-group-deutschland-gmbh/d3e5738f-5583-4a69-9c4a-0fea22f0be7e

> FDA WARNING_LETTER for Sorin Group Deutschland GmbH on September 01, 2015. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Sorin Group Deutschland GmbH
- Inspection Date: 2015-09-01
- Product Type: Devices
- Office Name: Center for Devices and Radiological Health
- Summary: The FDA issued a Warning Letter to LivaNova (formerly Sorin Group S.p.A.) following inspections of their Munchen, Germany, and Arvada, USA facilities in August-September 2015. The inspections revealed that their Stockert Heater Cooler 3T thermal regulator devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to furnish required information.

Key violations at the Munchen facility include:
1.  **Failure to establish and maintain procedures for design changes (21 CFR 820.30(i)):** Design Change Order #8115, intended to address prior deficiencies, had incomplete design input regarding water quality and inadequate design validation for cleaning Instructions for Use (IFU). Subsequent Design Change Orders (9416, 9416-01, 9711, 9690) related to a recall for updated cleaning IFUs also lacked adequate verification/validation, with issues in acceptance criteria, disinfectant equivalency, bacterial concentrations, water measurement accuracy, sampling methods, statistical rationale, and usability testing. This is a repeat violation from a 2011 Warning Letter.
2.

## Related Officers

- [Carrie Wood](https://www.keypedia.com/people/carrie-wood/84e3a8aa-efe3-4f5d-9250-4d2d2498d373)
- [Thierry Dupoux](https://www.keypedia.com/people/thierry-dupoux/b3202a54-45da-42ea-8735-e8a00cdc65a6)
- [Office Director](https://www.keypedia.com/people/sean-m-boyd/e9ac4789-b489-402d-8fb7-e20eed2af01f)

Company: https://www.keypedia.com/companies/sorin-group-deutschland-gmbh/fb18862c-90c0-4918-903c-9bbe6a7897db

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7