Getinge AB Responds to FDA and Accepts Datascope Inclusion in Existing Consent Decree Call (Media) Transcript
Welcome to Getinge Press Conference 2022. (Operator Instructions)
I will now hand over the word to CEO, Mattias Perjos. Please begin your meeting.
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Great. Thank you very much. And thanks, everyone, for tuning in with short notice. We can -- I will do a bit of a background information up here in just a few minutes, and then we can move very quickly to Q&A.
So if we move directly to Page #2, please. So the background here for the news today and this call is that Datascope, which is a subsidiary of Getinge and the manufacturer of life-supporting medical devices, such as our intra-aortic balloon pump, which are sold globally, we received a warning letter in 2019 from FDA related to findings in the organization's procedures and processes.
And then there was a follow-up inspection lasting from November 2021 to January 2022, and the findings from that inspection from FDA was that our operations are still not fully in compliance
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