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Ambu — Legal Proceedings Report 2013
Oct 29, 2013
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Download source fileKing Systems – owned by Ambu A/S – has received a Warning Letter from the U. S.
Food and Drug Administration (FDA) relating to an inspection of the King
Systems manufacturing site in Noblesville, USA. The Warning Letter references
King Systems’ reply to the inspectional observations left by the FDA at the
conclusion of the inspection.
The Warning Letter primarily addresses the timeline for validation of
manufacturing processes for some legacy products. All new products and
processes launched in the past 2.5 years have been validated, so this
observation applies to retroactively validating the legacy processes. The
Warning Letter is not expected to have consequences for products on the US
market and little, if any, in other markets.
King Systems and Ambu take the request from FDA very seriously and has replied
to FDA’s Warning Letter on October 21, 2013. This is part of the efforts to
bring the aforementioned processes to a higher standard than ever before.
Contact
Lars Marcher, President & CEO, tel. +45 5136 2490, email: [email protected]
Ambu A/S
Baltorpbakken 13
DK-2750 Ballerup
Tel. +45 7225 2000
CVR no.: 63 64 49 19
www.ambu.com