You are visiting a website that is not intended for your region

The page or information you have requested is intended for an audience outside the United States. By continuing to browse you confirm that you are a non-US resident requesting access to this page or information.

Switch to the US site

Notícias

Datascope, a subsidiary of Getinge, receives a warning letter from the US Food and Drug Administration (FDA) at the Mahwah site in the US

February 7, 2019 Gothenburg, Sweden

Datascope, a subsidiary of Getinge, receives a warning letter from the US Food and Drug Administration (FDA) at the Mahwah site in the US

Getinge’s production site in Mahwah, New Jersey, US, has received a warning letter from the US Food and Drug Administration. The warning letter originates from routine inspections during 2018 of the Datascope facilities in Mahwah and Fairfield.

FDA’s observations are related to procedures and processes linked to requirements on supplier control, design controls and changes, and the corrective and preventive actions (CAPA) procedure. Prior to the 2018 FDA inspection, the company self-identified the deficiencies through internal audit performed by Getinge. Since the end of 2017 a remediation plan has been in place and to resolve the deficiencies in the procedures and processes that were consistent with the FDA inspection. Based on current assessment, net sales and financial impact related to corrections of the findings are expected to be non-material. Production capacity is not deemed to be impacted by the inspection results. There are no known adverse events associated with serious injury or death.

As earlier communicated Getinge’s production unit at Datascope in Fairfield received a warning letter from the FDA in September 2018. The warning letter originated from an inspection by the FDA during spring 2018. As in Mahwah, a dedicated team is working on a correction plan since an internal inspection in November 2017. Getinge has submitted an action plan, including activities and a related schedule, to the FDA. Financial impact related to Fairfield observations are not expected to be material. The warning letters will remain open until the corrections have been verified by the agency.

Conference call

A conference call will be hosted by Mattias Perjos, President & CEO on Thursday February 7, 2019, at 4.45 p.m. CET.

Link to presentation and conference call details: https://financialhearings.com/event/11936

Telephone:
SE: +46 8 566 42694
UK: +44 3333 009 264
US: +1 844 625 1570

Contact:

Lars Mattsson, Head of Investor Relations
Phone: +46 (0)10 335 0043
E-mail: lars.mattsson@getinge.com

Anna Appelqvist, Vice President Corporate Communications
Phone: +46 (0)10 335 5906
E-mail: anna.appelqvist@getinge.com

Files

Compartilhar: